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NAUSEA RELIEVING PROPERTIES OF CANNABIS 1
BRANDMAN UNIVERSITY
Travis Air Force Base Campus
An Investigation of the Nausea Relieving Properties of Cannabis for Chemotherapy
Patients
A Paper Presented to Professor Nancy Brown
In Partial Fulfillment of the Requirements of the Bachelors’ of Arts Degree in
Criminal Justice
SSCU 494
June 26, 2014
By
Sarah Hooks
NAUSEA RELIEVING PROPERTIES OF CANNABIS 2
Abstract
Cannabis has been used for hundreds of years to assist humans with various
bodily problems. Research on cannabis and its effects on chemotherapy induced nausea
over the last 39 years shows that cannabis is proven to assist patients with their nausea
and vomiting. This study examined chemotherapy patients, and surveyed them to find out
of cannabis did or did not help alleviate their nausea during chemotherapy. It is predicted
that cannabis will help decrease chemotherapy patient’s nausea very well after
chemotherapy. Using data collected by a pilot study and research, an evaluation was
conducted on whether or not cannabis was an effective agent against chemotherapy
induced nausea. Results indicate that cannabis did help decrease chemotherapy patient’s
nausea very well after chemotherapy. Also, chemotherapy patients most likely turned to
cannabis if their traditional anti-nausea medicines fail. And last, overall, cannabis has
provided chemotherapy patients with more relief, and a better quality of life due to them
being able to relieve their nausea.
NAUSEA RELIEVING PROPERTIES OF CANNABIS 3
Introduction
Lance Armstrong, when speaking about cancer, said the following: “We have two
options, medically and emotionally: give up or fight like hell” (Armstrong, 2014).
Thousands of people in America fight cancer every day, and have to deal with various
negative side effects when experiencing chemotherapy. Nausea is one of these side
effects, that make having cancer that much more unbearable. The heart of this proposal is
to help people, and see the fight against cancer be a little more tolerable. The goal is to
explore how natural cannabis and synthetic cannabinoids can help chemotherapy patients.
It is important to understand how according to the American Cancer Society, “Cancer is
the second leading cause of death in the US, exceeded only by heart disease. One of
every four deaths in the US is from cancer. In 2014, about 585,720 people are expected to
die from cancer. That’s almost 1,600 per day” (American Cancer Society, 2014). This
startling statistic should be an eye opener to any human who cares about other humans. If
this many people suffer, it only makes sense to want to alleviate some of the pain they
should endure while fighting for their life. Just as the human body has organs each with
their own function, cancer is a function of a healthy society. The individuals with cancer
serve to provide doctors and nurses with a specific job, and researchers with a mission to
find relief for difficult symptoms due to chemotherapy. Once the chemotherapy patients
are able to thrive and pull through chemo, they can once again be part of the functioning
society. Initially, someone may see their cancer diagnosis as something negative, but in
reality, their illness keeps society in balance and motion. Back in 1986, the FDA
authorized the use of marijuana’s active element THC, for medical purposes (Walsh et al.
2003) to treat nausea and vomiting side effects in patients receiving chemotherapy”
NAUSEA RELIEVING PROPERTIES OF CANNABIS 4
(Rocha and Stefano). This research aims to find out if cannabis, either synthetic or not,
can help these cancer victims undergoing chemotherapy find relief from their nausea, and
be able to thrive and have a better quality of life.
Researchquestion: Does cannabis use decrease nausea in chemotherapy
patients?
Hypothesis: Cannabis use decreases nausea in chemotherapy patients.
Null hypothesis: Cannabis use does not decrease nausea in chemotherapy
patients.
Independent variable: Cannabis use
Dependent variable: Nausea level
The results of this study conclude that cannabis will help decrease chemotherapy
patient’s nausea very well after chemotherapy. Also, chemotherapy patients will most
likely turn to cannabis if their traditional anti-nausea medicines fail. And last, overall,
cannabis has provided chemotherapy patients with more relief, and a better life due to
them being able to relieve their nausea.
Literature Review
Research on cannabis and its effects on chemotherapy induced nausea over the
last 39 years shows that cannabis is proven to assist patients with their nausea and
vomiting. In America, a synthetic THC pill was created called Dronabinol. In the UK and
Canada, Nabilone was the synthetic THC pill of choice for chemotherapy patients, with a
very high potency. Although marijuana is illegal federally, some states allow it for
NAUSEA RELIEVING PROPERTIES OF CANNABIS 5
medicinal use. According to the Virtual Medical Centre, “Chemotherapy-induced nausea
and vomiting (abbreviated as CINV) affects 70–80% of people with cancer, and has a
significant impact on the patient and on healthcare resources” ("Chemotherapy-induced
nausea and," 2014). This prevalent topic has been at the forefront of scientific research
since the 1970’s. Much scientific and clinical effort has gone into testing various ways
for chemotherapy patients to have their nausea relieved, since this side effect can
sometimes be the most debilitating and unpleasant. According to Jayme Cotter (2009),
“CINV is an undesirable side effect; it is distressing physically and may result in
decreased quality of life. The sensation of nausea may compromise patients physically by
decreasing appetite, leading to poor nutrition or diminished movement that results in
muscle decompensation” (p. 345). The following peer reviewed research articles will
explain various ways for chemotherapy patients to use cannabis in the lessening of their
nausea.
Cannabis versus traditional anti-nausea medicine: The first form of relief from
nausea to be expected from a doctor to a chemotherapy patient is one of pharmaceutical
grade. The effectiveness of cannabis ultimately lies with the patient, and how they
perceive their nausea levels. In 1982, the Michigan Cancer Foundation (Musty & Rossi,
2001) conducted a randomized crossover study with 165 patients to test smoked
marijuana and thiethylperazine (traditional anti-nausea medication), for control of CINV”
(Cotter 2009, p.350). The marijuana and traditional anti emetics were administered before
chemotherapy started. The patients self reported their nausea levels, along with nurses
observing how nauseous the patients were after chemotherapy. This study concluded that
there was no significant benefit to cannabis versus the traditional medication. The gaps in
NAUSEA RELIEVING PROPERTIES OF CANNABIS 6
this study are noting how much THC was in the marijuana cigarettes, to see if perhaps the
patients should’ve been given more. Further research into a retest comparing a higher
level of THC in the marijuana cigarette versus the traditional anti-emetic should be
warranted. On the contrary, “Orr, McKernan, and Bloome (1980) compared oral THC,
prochlorperazine, and placebo in patients with severe CINV. The 55 patients with various
malignancies who participated in the double-blind, randomized crossover study were
receiving chemotherapies of moderate to very high emetic potentials” (Cotter p. 349).
The medicine was administered before chemotherapy, and afterwards the patients rated
their nausea within 24 hours of receiving the drug. This study concluded that, “Oral THC
was significantly more effective in controlling CINV with moderately to highly
emetogenic (vomit inducing) chemotherapies. A staggering 73% of patients who took the
THC pill experienced complete nausea relief, while 15% saw relief through the
prochlorperazine, and 9% saw relief with the placebo (Cotter p. 347). In this case, the
cannabis had a profound effect on lessening the nausea for the patients. In this particular
trial, cannabis once again provided the most substantial relief from nausea. I believe these
clinical trials relate to my proposed research because if a chemotherapy patient has an
adverse reaction to marijuana in any form, they can always fall back on a traditional anti-
nausea medication to try and neutralize their nausea. It should be noted, however, that
these traditional anti-emetics such as thiethylperazine have an extensive list of possible
side effects to include, “dryness of the mouth and nose, blurred vision, tremor, weight
gain, incontinence, and fever” ("Torecan (thiethylperazine)," 2014). The noted side
effects from cannabis were sleepiness, sore throat, or a headache (Musty & Rossi, 2001).
NAUSEA RELIEVING PROPERTIES OF CANNABIS 7
A patient may want to weigh each option and determine if their relief from nausea is
more important than side effects from either traditional anti-emetics or cannabis.
Cannabis versus placebo: In the interest of exploring how chemotherapy patients
perceive nausea, various trials have been done to test marijuana versus a placebo. It is
important to remember that just like pain, nausea can be subjective. In 1979, Frytak et al.
compared prochlorperazine, THC and placebo to treat CINV. 116 patients with GI cancer
were given THC, placebo or the traditional anti-emetic two hours prior to chemo.
According to Cotter, “Treatment effects, including nausea and vomiting, sedation,
coordination, and feelings of being “high” were evaluated by participant interviews” (p.
349). This study is quite similar to the one done by Orr, McKernan, and Bloome, because
the same substances were tested. The difference was that in the study by Frytek, “No
statistically significant difference was observed between THC and prochlorperazine in
regard to their antiemetic properties” (Cotter p. 349). But in both studies, the placebo
provided relief to a miniscule amount of people. As with any placebo, there is the
possibility that those patients thought they were receiving a real medication, whether it be
THC or traditional, and their brains convinced themselves that the nausea was gone. As
previously mentioned, nausea is a subjective experience. I believe this related to my
proposed research because the research I am proposing focuses on relieving
chemotherapy induced nausea, and these studies made it clear that cannabis in any form
helped reduce their nausea. My research also seeks to find out the best way for
chemotherapy patients to find relief. If Frytek found no apparent difference in relief
between cannabis and traditional medicine, it would be worth a more current retrial.
NAUSEA RELIEVING PROPERTIES OF CANNABIS 8
New forms of cannabis: A new synthetic THC pill called Namisol has been only
tested once in clinical trials, but the research aims to evaluate how quickly a patient can
receive relief from CINV, and how effective it can be. The aim for this new drug
Namisol, is to harness the most pure form of THC in a pill, and have it be working for the
patient in a small amount of time. In 2011, Klumpers & Beumer, et al published a study
involving the most efficient administration of Namisol in humans. The authors note how,
“This is a first in human trial investigating the optimal administration route of Namisol,
the safety, pharmacokinetics, pharmacodynamics and tolerability” (Klumpers & Beumer,
et al 2012, p. 43). Since the pill is so new, the first tests aim to find the quickest onset as
well as effectiveness versus the other synthetic THC pills. According to Klumpers and
Beumer, et al, “Namisol is well-tolerated and absorbed quickly after ingestion, and
reaches peak plasma concentrations within 1 h and maximal effects between 1 to 2 h after
administration. Compared with the literature on registered dronabinol formulations and
cannabis based medicines, these results imply that Namisol may also have favorable
pharmacokinetic and pharmacodynamic characteristics in patients” (Klumpers & Beumer
et al 2012). Suggestions for further research include more trials with Namisol compared
to traditional THC pills, and Namisol against smoked marijuana. There could also be
further studies conducted on when Namisol should be administered to achieve nausea
relief the fastest, whether it is an hour before chemotherapy, or right after chemotherapy.
I believe this is related to my research proposal because the aim is to find out how
chemotherapy patients can find relief from nausea through cannabis. Namisol could very
well be the most pure and efficient THC pill to administer to chemotherapy patients who
have an aversion to smoking cannabis. My data that I gather will examine the best ways
NAUSEA RELIEVING PROPERTIES OF CANNABIS 9
to relieve cannabis, and find out through a survey what types of cannabis have been
utilized.
Merging the traditional and alternative: A chemotherapy patient should not be
limited in their regime to find relief from nausea. If the possibility exists to merge
traditional anti-nausea medicines with a synthetic THC oral spray, that option deserves to
be on the table for chemotherapy patients. In 2009, Duran et al. ran a, “pilot, randomized,
double-blind, placebo-controlled phase II clinical trial designed to evaluate the
tolerability of an acute dose titration of Sativex (oral spray), containing THC and
cannabidiol, taken in conjunction with standard therapies in the control of CINV” (Duran,
et al 2009). Cotter (2009) analyzes how, “ The addition of the cannabinoids to existing
antiemetic regimens may provide increased relief of CINV, resulting in better quality of
life and overall health of patients with cancer” (p. 351). The idea to mix medicinal
cannabis and traditional regimes is a relatively new idea, since this study was only
published 4 years ago. Further trials should be warranted to see if the combination of anti
emetics and Sativex could be the best way to treat chemotherapy induced nausea and
vomiting. The question still remains of what treatment is ultimately best for CINV. As
more research is compiled on the medicinal benefits of cannabis for chemotherapy
patients, perhaps the most fruitful mixture of medicines will help these people find relief
without unpleasant side effects. I believe this is related to my research because finding
the best relief from nausea is the ultimate goal for chemotherapy patients. If a medicine
such as Sativex could provide the quickest relief, with the least amount of side effects,
this should be the first treatment option available for chemotherapy patients by doctors.
My research may also find that the oral spray is the easiest to administer to chemotherapy
NAUSEA RELIEVING PROPERTIES OF CANNABIS 10
patients who don’t like to smoke or can’t stand to swallow a pill due to their nausea. But
the further testing and data analysis would need to be provided to back up the argument
in favor of Sativex. If a fast acting, absolute relief from nausea can be created, society
can continue its circle of healthy functioning through healthier chemotherapy patients,
who contribute to a well-balanced society.
Theoretical Foundations
The theory I chose that meshes best with my research question is the functionalist
theory by Emile Durkheim. According to Functionalism, “Each aspect of society is
interdependent and contributes to society's functioning as a whole. If all goes well, the
parts of society produce order, stability, and productivity” (“Three major perspectives”,
2014). Since my research revolves around getting through chemotherapy in the most
comfortable way possible, it’s focused on people who are sick. In Durkheim’s theory, he
speaks of how society is a product of all the parts. If a part of society (people with
cancer) is sick, the natural order is to make them well again. It’s just like if someone’s leg
is broken, they can’t function to their fullest potential until the leg heals. Someone who
has constant nausea may not be able to eat, and if they can’t eat, they can’t thrive and get
well again. If they take cannabis and decrease or get rid of their nausea, and they can eat,
and then they can push through the chemotherapy and get well again. Once well, these
once sickly people can now contribute to the greater society, and help be productive
members of that society. Someone who had a profound experience during their
chemotherapy may just end up helping others, or spreading around information about
how they made it through. If cannabis can be at the forefront of treatment for
NAUSEA RELIEVING PROPERTIES OF CANNABIS 11
chemotherapy induced nausea, then others can potentially find relief sooner, and get
through chemotherapy with less misery, and reach their full potential quicker. Another
supporter of Functionalism was Talcott Parsons. He believed that, “Society is the way it
is as social structures are interconnected and dependent on each other” (Bryant, 2011).
Even though people with chemotherapy are sick, they are still contributing to the
productivity of society by giving doctors, nurses, nutritionists, and medical staff jobs.
They are spurring more research into proposals like mine, and making the rest of the
healthy world look more into cancer and the relief from unpleasant chemotherapy side
effects. On the surface, chemotherapy patients may seem like a burden on a society, when
in reality society needs the ill as much as the ill need people to make them well again.
Methodology and Research Methods
The research I’m proposing is to find out if cannabis lessens nausea in
chemotherapy patients. The independent variable is cannabis use, and the dependent
variable is level of nausea. Cannabis use is defined as smoking a marijuana cigarette,
using THC oil, using a THC Oral Spray, eating foods/drinks infused with THC,
(brownies, cookies, tea), or inhaling vapor. Nausea is defined as feeling like one has to
throw up. To measure if nausea was relieved, the survey will have a scale of Poorly (Felt
nauseous frequently), Acceptably (Minimal Nausea), Very Well (Nausea maybe once a
day), and Completely knocked out Nausea. The research I conduct will be quantitative,
because it is a survey that serves to measure effectiveness against nausea and
effectiveness of cannabis. The respondents must have had chemotherapy at one point in
their life, which may or may not be indicative of having cancer. But usually, people go
NAUSEA RELIEVING PROPERTIES OF CANNABIS 12
through chemotherapy to lessen the size of their tumors, and to try and stop cancer from
getting progressively worse. As I learned through my pilot study, some people go through
chemotherapy for other reasons and diseases, like lupus.
Participants
I intend to have a sample size of roughly 200 chemotherapy patients, from all
around California. I will accept people of all races and ethnicities, any age, any
profession, and at any stage of chemotherapy. If someone had chemotherapy 6 years ago,
his or her opinions are still valid. I chose a sample size of 200 because that seems to be
the average size I’ve researched about, and those results were the ones published. Also, a
sample size that large would produce results that were statistically significant.
Instrument
My instrument is a 10- question survey. I will take what I learned in the pilot
study and vary the questions accordingly. I will explain each question, and its attributes.
Question 1: What is your gender? The attributes are: Male and Female. This is the only
type of demographic information I require, since the research is about whether or not
cannabis helps relieve nausea in chemotherapy patients. I am not concerned if their
ethnicity relates to their cannabis helping with the nausea. Question 2: What stage of
cancer did you have at your diagnosis? Attributes: Stage 0 (Stage 0 cancers are still
located in the place they started and have not invaded nearby tissues. This stage of cancer
is often highly curable, usually by removing the entire tumor with surgery); Stage I (This
is usually a small cancer or tumor that has not grown deeply into nearby tissues and has
not spread to the lymph nodes or other parts of the body); Stage II (These stages indicate
cancers or tumors that are larger in size, have grown more deeply into nearby tissue, and
NAUSEA RELIEVING PROPERTIES OF CANNABIS 13
have spread to lymph nodes, but not to other parts of the body.); Stage III; and Stage IV
(cancer has spread to other organs or parts of the body. It may also be called advanced or
metastatic cancer.) I will have a last option as: Had non-cancer diagnosis. This will cover
anyone who had another disease. Question 3: What type of chemotherapy drugs did
doctors give you to fight your cancer? The attributes are as follows: Alkylating agents,
Antimetabolites, Anti-tumor antibiotics, Topoisomerase or Mitotic inhibitors,
Corticosteroids, Miscellaneous chemo drugs, or other. I am not going to list out examples
of each, since there are hundreds of types of drugs. If a person is unsure of what class
their drugs are in, they can ask their doctor. I will make this question one that the
respondent can select multiple answers, if they’re on a regime of multiple drugs.
Question 4: What level of emetogenicity (vomit inducing potential) were your chemo
drugs? The attributes are: High, Moderate, Minimal, or Unsure. Question 5: Which anti-
emetic drugs (effective against nausea and vomiting) did you try? The attributes are:
None, Traditional, Steroids, Dopamine Antagonists, or Other. The other option will be
open ended, so the respondent can fill in their medicines. Question 6: What type of
cannabis did you use to control your nausea? The attributes are: None, Marijuana
Cigarette, THC Oil, Oral Spray, Edibles, or Vapor. This question will have the option to
select multiple answers. Question 7: How well did traditional medicines conquer your
nausea from chemo? The attributes are: Never used traditional medicines, Poorly (Felt
nauseous frequently), Acceptably (Minimal nausea), Very Well (Nausea maybe once a
day), and Completely knocked out my nausea. Question 8: How well did Cannabis
conquer your nausea from chemo? Attributes: Never used cannabis, Poorly (Felt
nauseous frequently), Acceptably (Minimal nausea), Very Well (Nausea maybe once a
NAUSEA RELIEVING PROPERTIES OF CANNABIS 14
day), and Completely knocked out my nausea. Question 9: If you have never used
cannabis to control your nausea from chemotherapy, would you try it? Attributes: Yes,
No, Not Applicable. Question 10: How important was relieving your nausea during
chemotherapy? Attributes: Not important, A little bit important, Very important, and A
matter of eating or not eating for me. These are all the survey questions, with some being
only answerable with one choice, and others have the option of choosing multiple
answers.
Procedures
My procedure for the large-scale survey are to seek out chemotherapy patients,
make a quality survey, give the patients the survey via mail, in person, and on the
internet, and try and get responses in a timely manner. This survey, when administered
online, will only be send to the intended recipients. Getting people to participate in the
survey requires contacting them in some way, through email, telephone, or physically
going to the cancer treatment center. Another way of initial contact, as used in the pilot
study, is to post on an online forum my plan for the survey, and see who responds. Since
this is a California-wide survey, I could only drive locally. I would have to telephone or
email everyone else. The people who have the survey emailed to them will be able to
return it quicker, so email may be the best way to save money and disperse surveys in a
quick manner. Those who have a hard-copy survey may take more time to respond, due
to the mail system. Also, a consent form needs to be drafted and dispersed, so the
respondents understand that the survey is completely anonymous and confidential, and
will only be used in my SSCU 494 class. Once all surveys have been dispersed, there will
NAUSEA RELIEVING PROPERTIES OF CANNABIS 15
be a waiting period of about one to two months to receive back all data and start
analyzing it. I will explore the data for trends and patterns, and see if the results from the
pilot study matched results from the larger study.
Limitations
Just with any research method, surveys have limitations. There is a potential for
bias from people who are pro-cannabis before they were diagnosed with chemotherapy,
and the people who have been avid smokers before they needed it medically. Also,
people who have no Internet, or are not well enough to complete a survey would not be
able to be reached. Also, it is worth mentioning that different ethnicities relate to
subjective events like nausea, perhaps differently. One person may perceive a quick wave
of nausea as extreme, while another person may see that as mild. Last, the cost to print
out, mail, then pick up hundreds of surveys may prove an issue.
Anticipated Findings
My research begged the question: Does cannabis use decrease nausea in
chemotherapy patients? Through my research and my pilot study, the data indicates that
cannabis helps a majority of either surveyed or tested chemotherapy patients reduce or
eliminate their nausea after chemotherapy. Therefore, I reject the null hypothesis that
states: Cannabis use does not decrease nausea in chemotherapy patients.
I expect my research to reveal three major findings. The first finding I expect is
that cannabis will help decrease chemotherapy patient’s nausea very well after
chemotherapy. Very well is defined as having nausea perhaps once a day. In some results
NAUSEA RELIEVING PROPERTIES OF CANNABIS 16
from my pilot study, out of 13 patients, 53.85% reported that cannabis conquered their
nausea very well after chemotherapy. In lieu of this, I expect these results to be similar in
a larger study. These patients turned to a variety of types of cannabis through different
routes, but the relief came to all but a few patients. Overall, at least 84.61% of patients
who used cannabis saw at least an acceptable amount of relief (minimal nausea) or better
after their chemotherapy. This insinuates that cannabis is an effective reliever of nausea
for some people.
The second finding I expect to see is that chemotherapy patients will most likely
turn to cannabis if their traditional anti-nausea medicines fail. I expect these findings to
also be evident in the larger study that would be completed. The Institute of Medicine
published in its Mar. 1999 report titled "Marijuana and Medicine: Assessing the Science
Base":" It is possible that the harmful effects of smoking marijuana for a limited period
of time might be outweighed by the antiemetic benefits of marijuana, at least for patients
for whom standard antiemetic therapy is ineffective and who suffer from debilitating
emesis" (J. Joy, S. Watson, Jr. & J. Benson, Jr. (Eds.), 1999). For some patients,
traditional medicines fail, and they must find alternatives to deal with their nausea.
Cannabis can be that alternative. Also, according to information from my pilot study,
53% of chemotherapy patients answered that their traditional anti-nausea medication
provided poor relief from nausea. Poor relief is defined as still feeling nauseous
frequently.
The third finding I expect is to see that overall, cannabis has provided
chemotherapy patients with more relief, and a better life due to them being able to relieve
their nausea. If a chemotherapy patient’s nausea is conquered, they can get back into their
NAUSEA RELIEVING PROPERTIES OF CANNABIS 17
regular workflow and be a functioning member of society again. Kate Scannell, MD, Co-
Director of the Kaiser-Permanente Northern California Ethics Department, wrote the
following in the Feb. 16, 2003 article "Mr. Attorney General, Listen to the Doctors"
published in the San Francisco Chronicle: "I knew this woman was dying a prolonged
and miserable death. And, from years of clinical experience, I - like many other doctors -
also knew that marijuana could actually help her. From working with AIDS and cancer
patients, I repeatedly saw how marijuana could ameliorate a patient's debilitating fatigue,
restore appetite, diminish pain, remedy nausea, cure vomiting and curtail down-to-the
bone weight loss. I could firmly attest to its benefits and wager the likelihood that it
would decrease her suffering." (Scannell, 2003). As Dr. Scannell and hundreds of others
understand, cannabis can truly help people who need to restore balance back in their
lives, and finally feel some relief that they deserve.
Conclusion with Policy Recommendations
I delved into this research with the intentions to seek out the most effective and
natural way for chemotherapy patients to find relief from their nausea. Having relief from
nausea not only means feeling better, but it also allows the patient to eat normally, and
have a better overall health, given their circumstances. Some gaps in my research still
exist, such as finding out which combination of medicine will work best. This could
either be synthetic and natural cannabis; or it could be a mixture of a traditional anti-
emetic and cannabis. More clinical trials will need to be completed in that arena, in
addition to more focus on the new up and coming THC pills on the market. Next, a gap in
my research is delving in to the arena of whether or not cannabis and cannabinoids
NAUSEA RELIEVING PROPERTIES OF CANNABIS 18
should be on the front line of defense for chemotherapy induced nausea, instead of other
traditional anti-emetics. The future will hold the key to finding out the quickest, most
natural and helpful relief for these suffering from chemotherapy induced nausea. Perhaps
with further research, lives can be improved sooner. Even though a cancer diagnosis
seems bleak, it is all part of the overall function of a healthy society. I would send this
research proposal to Oncologists around the country, as well as the American Cancer
Society, and policy makers in Washington in an effort to make a change in the procedure
of certain policies. The policy change I would like to see is to have cannabis at the
forefront of nausea relief, and the first line of defense, instead of an alternative medicine.
The goal is to benefit the suffering community of cancer patients who deserve relief from
their nausea.
NAUSEA RELIEVING PROPERTIES OF CANNABIS 19
APPENDIX I
Item 1 (GENDER)
What is your gender?
1= Male; 2= Female
Item 2 (STAGE)
What stage of cancer did you have at your diagnosis?
1= Stage 0 (Stage 0 cancers are still located in the place they started and have not invaded
nearby tissues. This stage of cancer is often highly curable, usually by removing the
entire tumor with surgery) 2= Stage I (This is usually a small cancer or tumor that has not
grown deeply into nearby tissues and has not spread to the lymph nodes or other parts of
the body) ; 3= Stage II (II & III) These stages indicate cancers or tumors that are larger in
size, have grown more deeply into nearby tissue, and have spread to lymph nodes, but not
to other parts of the body.) ; 4= Stage III; 5= Stage IV (cancer has spread to other organs
or parts of the body. It may also be called advanced or metastatic cancer.)
Item 3 (CHEMOMED)
What type of chemotherapy drugs did doctors give you to fight your cancer?
1= Alkylating agents; 2= Antimetabolites; 3= Anti-tumor antibiotics; 4= Topoisomerase
or Mitotic inhibitors; 5= Corticosteroids ; 6= Miscellaneous chemo drugs; 7= Other
(Differentiating agents, hormone therapy, immunotherapy)
Item 4 (STRENGTH)
What level of emetogenicity (vomit inducing potential) were your chemo drugs?
1= high emetogenic potential; 2= moderately emetogenic potential; 3= minimal
emetogenic potential; 4= Unsure
Item 5 (CINV)
Which anti-emetic drugs did you try?
1= None; 2= Traditional (Anzemet, Kytril, Zofran, Aloxi,); 3= Steroids (Decadron,
Medrol,); 4= Dopamine Antagonists (Inapsine, Haldol, Reglan, Compazine, Phenergan);
5= Other
Item 6 (CANNABIS)
What type of cannabis did you use to control your nausea?
1= None; 2= Marijuana cigarette; 3= THC Oil; 4= THC Oral-mucosal spray; 5=
Marijuana in anything edible; 6= Synthetic THC Pill (Marinol, Cesamet, Namisol), 7=
Vapor
Item 7 (TRADITION)
How well did traditional anti-emetics conquer your nausea from chemo?
1= Never used traditional; 2= Poorly (Felt nauseous frequently); 3= Acceptably (Minimal
nausea); 4= Very Well (Nausea maybe once a day); 5= Completely knocked out my
nausea
NAUSEA RELIEVING PROPERTIES OF CANNABIS 20
Item 8 (CANNACUR)
How well did cannabis conquer your CINV?
1= Never used cannabis; 2= Poorly (Felt nauseous frequently); 3= Acceptably (Minimal
nausea); 4= Very Well (Nausea maybe once a day); 5= Completely knocked out my
nausea
Item 9 (NEVER)
If you never used cannabis to control your nausea from chemotherapy, would you try it?
1= yes; 2=No; 3= Not Applicable
Item 10 (IMPORTAN)
How important was relieving your nausea during chemotherapy?
1= Not important; 2= A little bit important 3= Very important 4= A matter of eating or
not eating for me
NAUSEA RELIEVING PROPERTIES OF CANNABIS 21
APPENDIX II
Please read this consent agreement carefully before you decide to participate in the
survey.
Project Title: An Investigation of the Nausea Relieving Properties of Cannabis for
Chemotherapy Patients
Researcher: Sarah Hooks, Brandman University, Fairfield CA
The purpose of this research study is to understand if cannabis can relieve nausea in
chemotherapy patients.
In this study you will be asked to complete 10 survey questions, and if given a hardcopy
study, mail it back to Sarah Hooks.
Risks: There is a slight risk that this study may make you upset. If it does, you may quit
at any time.
Benefits: There are no guaranteed benefits to you for participating in this research study.
You will receive no payment for participating in this study.
Confidentiality: The information that you give in the study will be handled confidentially.
The information you provide will not be linked back to you.
Your participation in the study is completely voluntary. You have the right to withdraw
from the study at any time without penalty.
If you have questions about the study, contact: Sarah Hooks, shooks@mail.brandman.edu
If you have questions about your rights in the study, contact: Professor Nancy Brown
NAUSEA RELIEVING PROPERTIES OF CANNABIS 22
References:
2007 weight loss. (2007, JAN). Men's Health, 135. Retrieved from
http://books.google.com/books?id=0scDAAAAMBAJ&pg=PA135&lpg=PA
135&dq=We have two options, medically and emotionally: give up or fight
like hell&source=bl&ots=lxzMEQypR7&sig=4wdp3QNSM8_W5YyOGJ-
JJiM7UdY&hl=en&sa=X&ei=jOB1U7eUK4LvoAS54YCIBQ&ved=0CD4Q6
AEwBjgK
American Cancer Society. Cancer Facts & Figures 2014. Atlanta: American Cancer
Society; 2014.
Cancer statistics by cancer type. (2013, SEP 25). Retrieved from
http://www.cdc.gov/cancer/dcpc/data/types.htm
Cannabis. (2014, MAY 15). Retrieved from http://www.merriam
webster.com/dictionary/cannabis
Chemotherapy. (2014, MAY 15). Retrieved from http://www.merriam-
webster.com/dictionary/chemotherapy
Chemotherapy-induced nausea and vomiting (cinv). (2014, JAN 27). Retrieved from
http://www.myvmc.com/symptoms/chemotherapy-induced-nausea- and-vomiting-cinv/
Cotter, J. (2009). Efficacy of crude marijuana and synthetic Delta-9-
Tetrahydrocannabinol as treatment for chemotherapy-induced nausea and
vomiting: a systematic literature review. Oncology Nursing Forum, 36(3), 345-
352. doi:10.1188/09.ONF.345-352
This researcher set out to compare how cancer patients felt when smoking “crude”
cannabis versus taking a synthetic form of THC to help with their chemotherapy induced
nausea and vomiting (CINV). This article is a summation of research on 10 clinical trials
found through MEDLINE, CINAHL and Cochrane Library. The 10 studies (usually
randomized, crossover, double blind; although some not randomized, with most having
placebo) had anywhere from 15- 214 chemotherapy patients, who either took a synthetic
THC pill, smoked a marijuana cigarette, took a traditional anti-emetic drug, or had a
placebo. The main conclusion was that the synthetic THC pill and crude marijuana were
highly effective in reducing nausea and vomiting, whereas the placebo did not help
reduce vomiting. In some studies, both the traditional anti-emetic drug and THC both
provided relief from nausea and vomiting. This article applies to my research proposal
because it helps me understand just how helpful THC (cannabis) is for cancer patients
with nausea and vomiting. There are, however, drawbacks for using the THC pills/
smoking: it seems there may be side effects of feeling high and coordination decreasing.
Future research into the benefits of combining a traditional anti-emetic drug with a THC
pill could prove to be the most effective treatment for CINV.
NAUSEA RELIEVING PROPERTIES OF CANNABIS 23
Duran, M., Pérez, E., Abanades, S., Vidal, X., Saura, C., Majem, M., & ... Capellà, D.
(2010). Preliminary efficacy and safety of an oromucosal standardized cannabis
extract in chemotherapy-induced nausea and vomiting. British Journal Of Clinical
Pharmacology, 70(5), 656-663. doi:10.1111/j.1365-2125.2010.03743.x
Frytak, S., Moertel, C.G., O’Fallon, J.R., Rubin, J., Creagan, E.T., O’Connell, M.J., et al.
(1979). Delta-9-tetrahydrocannabinol as an antiemetic for patients receiving
cancer chemotherapy. A comparison with prochlorperazine and a placebo. Annals
of Internal Medicine, 91(6), 825–830.
Klumpers, L. E., Beumer, T. L., van Hasselt, J. C., Lipplaa, A., Karger, L. B.,
Kleinloog, H., & ... van Gerven, J. A. (2012). Novel Δ9-tetrahydrocannabinol
formulation Namisol® has beneficial pharmacokinetics and promising
pharmacodynamic effects. British Journal Of Clinical Pharmacology, 74(1),
42-53. doi:10.1111/j.1365-2125.2012.04164.x
This article aims to measure the effects of a new THC tablet called Namisol, and how
quickly it is absorbed into the human body compared with the other two synthetic
cannabis drugs. The study was conducted with two panels of tests. The first panel was to
determine the most favorable administration route either oral or sublingual (under the
tongue), using 12 people (6 male and 6 female), in a double blind, double dummy, two-
way crossover study. The second panel, to determine how different doses affect the
human body, utilized 9 people of mixed gender in a randomized, double blind, placebo
controlled trial. The people were between the ages of 18 to 55, and had a BMI between
18- 28 kg m. They had to have used cannabis for a year before the study. The main
finding of the panels were that Namisol was more effective when administered orally,
compared with sublingually (under the tongue). The dosage panels all experienced
dizziness as an adverse side effect, with doses of 8.0 mg THC, 6.5 mg THC, and placebo.
Also, all non-placebo groups felt euphoric. This study relates to my proposal because it
sheds light on the fast acting nature of this new THC tablet Namisol compared with
Nabilone, another synthetic THC pill. This could be useful for chemotherapy patients
who need quick relief, and who don’t want to smoke cannabis. Future research on more
clinical trials with Namisol is needed to be able to sufficiently say it is the best synthetic
form of THC on the market.
Marijuana and medicine: Assessing the science base. In (1999). J. Joy, S. Watson,
Jr. & J. Benson, Jr. (Eds.), Washington, D.C: NATIONAL ACADEMY
PRESS. Retrieved from
http://medicalmarijuana.procon.org/sourcefiles/IOM_Report.pdf
Musty, R., & Rossi, R. (2001). Effects of smoked cannabis and oral delta9-
tetrahydrocannabinol on nausea and emesis after cancer chemotherapy: a review
of state clinical trials. Journal Of Cannabis Therapeutics, 1(1), 29-42.
NAUSEA RELIEVING PROPERTIES OF CANNABIS 24
Orr, L.E., McKernan, J.F., & Bloome, B. (1980). Antiemetic effect of
tetrahydrocannabinol. Compared with placebo and prochlorperazine
in chemotherapy-associated nausea and emesis. Archives of Internal
Medicine, 140(11), 1431–1433.
Rocha, F., Stefano, S. C., Haiek, R., Oliveira, L., & Da Silveira, D. X. (2008).
Therapeutic use of Cannabis sativa on chemotherapy-induced nausea and
vomiting among cancer patients: systematic review and meta-analysis.
European Journal Of Cancer Care, (5), 431. doi:10.1111/j.1365-
2354.2008.00917.x
The main research question of this summation of studies was whether or not
cannabinoids can help with chemotherapy patients and their nausea and vomiting. This
article covered a multitude of studies; the various research methods included randomized,
crossover, parallel, paired, and double blind studies. Most studies focused on cancer
patients both young and old. All patients either had a form of cancer (lung) or a type of
tumor (carcinoma, sarcoma, breast, ovary). The main finding was that the cannabinoids
helped greatly with nausea and vomiting compared to regular drugs. However, the
cannabinoids also produced more side effects than regular drugs. Some side effects were
pleasant, while others were unpleasant. This article relates to my study because it sheds
light on my inquiry about if cannabis can help with nausea in chemo patients. Some
suggestions for future research are further clinical trials testing cannabinoids and modern
medicines, to gain further data.
Scannell, K. (2003, FEB 16). Medical marijuana / Mr. attorney general, listen to the
doctors and patients / john Ashcroft, meet a cancer victim. San Francisco
Chronicle. Retrieved from
http://www.sfchronicle.com/opinion/article/MEDICAL-MARIJUANA-Mr-
Attorney-General-Listen-2669856.php
Walsh D., Nelson K.A. & Mahmoud F.A. (2003) Established and potential
therapeutic applications of cannabinoids in oncology. Support Care Cancer 11,
137–143.

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Hooks_FinalProposal

  • 1. NAUSEA RELIEVING PROPERTIES OF CANNABIS 1 BRANDMAN UNIVERSITY Travis Air Force Base Campus An Investigation of the Nausea Relieving Properties of Cannabis for Chemotherapy Patients A Paper Presented to Professor Nancy Brown In Partial Fulfillment of the Requirements of the Bachelors’ of Arts Degree in Criminal Justice SSCU 494 June 26, 2014 By Sarah Hooks
  • 2. NAUSEA RELIEVING PROPERTIES OF CANNABIS 2 Abstract Cannabis has been used for hundreds of years to assist humans with various bodily problems. Research on cannabis and its effects on chemotherapy induced nausea over the last 39 years shows that cannabis is proven to assist patients with their nausea and vomiting. This study examined chemotherapy patients, and surveyed them to find out of cannabis did or did not help alleviate their nausea during chemotherapy. It is predicted that cannabis will help decrease chemotherapy patient’s nausea very well after chemotherapy. Using data collected by a pilot study and research, an evaluation was conducted on whether or not cannabis was an effective agent against chemotherapy induced nausea. Results indicate that cannabis did help decrease chemotherapy patient’s nausea very well after chemotherapy. Also, chemotherapy patients most likely turned to cannabis if their traditional anti-nausea medicines fail. And last, overall, cannabis has provided chemotherapy patients with more relief, and a better quality of life due to them being able to relieve their nausea.
  • 3. NAUSEA RELIEVING PROPERTIES OF CANNABIS 3 Introduction Lance Armstrong, when speaking about cancer, said the following: “We have two options, medically and emotionally: give up or fight like hell” (Armstrong, 2014). Thousands of people in America fight cancer every day, and have to deal with various negative side effects when experiencing chemotherapy. Nausea is one of these side effects, that make having cancer that much more unbearable. The heart of this proposal is to help people, and see the fight against cancer be a little more tolerable. The goal is to explore how natural cannabis and synthetic cannabinoids can help chemotherapy patients. It is important to understand how according to the American Cancer Society, “Cancer is the second leading cause of death in the US, exceeded only by heart disease. One of every four deaths in the US is from cancer. In 2014, about 585,720 people are expected to die from cancer. That’s almost 1,600 per day” (American Cancer Society, 2014). This startling statistic should be an eye opener to any human who cares about other humans. If this many people suffer, it only makes sense to want to alleviate some of the pain they should endure while fighting for their life. Just as the human body has organs each with their own function, cancer is a function of a healthy society. The individuals with cancer serve to provide doctors and nurses with a specific job, and researchers with a mission to find relief for difficult symptoms due to chemotherapy. Once the chemotherapy patients are able to thrive and pull through chemo, they can once again be part of the functioning society. Initially, someone may see their cancer diagnosis as something negative, but in reality, their illness keeps society in balance and motion. Back in 1986, the FDA authorized the use of marijuana’s active element THC, for medical purposes (Walsh et al. 2003) to treat nausea and vomiting side effects in patients receiving chemotherapy”
  • 4. NAUSEA RELIEVING PROPERTIES OF CANNABIS 4 (Rocha and Stefano). This research aims to find out if cannabis, either synthetic or not, can help these cancer victims undergoing chemotherapy find relief from their nausea, and be able to thrive and have a better quality of life. Researchquestion: Does cannabis use decrease nausea in chemotherapy patients? Hypothesis: Cannabis use decreases nausea in chemotherapy patients. Null hypothesis: Cannabis use does not decrease nausea in chemotherapy patients. Independent variable: Cannabis use Dependent variable: Nausea level The results of this study conclude that cannabis will help decrease chemotherapy patient’s nausea very well after chemotherapy. Also, chemotherapy patients will most likely turn to cannabis if their traditional anti-nausea medicines fail. And last, overall, cannabis has provided chemotherapy patients with more relief, and a better life due to them being able to relieve their nausea. Literature Review Research on cannabis and its effects on chemotherapy induced nausea over the last 39 years shows that cannabis is proven to assist patients with their nausea and vomiting. In America, a synthetic THC pill was created called Dronabinol. In the UK and Canada, Nabilone was the synthetic THC pill of choice for chemotherapy patients, with a very high potency. Although marijuana is illegal federally, some states allow it for
  • 5. NAUSEA RELIEVING PROPERTIES OF CANNABIS 5 medicinal use. According to the Virtual Medical Centre, “Chemotherapy-induced nausea and vomiting (abbreviated as CINV) affects 70–80% of people with cancer, and has a significant impact on the patient and on healthcare resources” ("Chemotherapy-induced nausea and," 2014). This prevalent topic has been at the forefront of scientific research since the 1970’s. Much scientific and clinical effort has gone into testing various ways for chemotherapy patients to have their nausea relieved, since this side effect can sometimes be the most debilitating and unpleasant. According to Jayme Cotter (2009), “CINV is an undesirable side effect; it is distressing physically and may result in decreased quality of life. The sensation of nausea may compromise patients physically by decreasing appetite, leading to poor nutrition or diminished movement that results in muscle decompensation” (p. 345). The following peer reviewed research articles will explain various ways for chemotherapy patients to use cannabis in the lessening of their nausea. Cannabis versus traditional anti-nausea medicine: The first form of relief from nausea to be expected from a doctor to a chemotherapy patient is one of pharmaceutical grade. The effectiveness of cannabis ultimately lies with the patient, and how they perceive their nausea levels. In 1982, the Michigan Cancer Foundation (Musty & Rossi, 2001) conducted a randomized crossover study with 165 patients to test smoked marijuana and thiethylperazine (traditional anti-nausea medication), for control of CINV” (Cotter 2009, p.350). The marijuana and traditional anti emetics were administered before chemotherapy started. The patients self reported their nausea levels, along with nurses observing how nauseous the patients were after chemotherapy. This study concluded that there was no significant benefit to cannabis versus the traditional medication. The gaps in
  • 6. NAUSEA RELIEVING PROPERTIES OF CANNABIS 6 this study are noting how much THC was in the marijuana cigarettes, to see if perhaps the patients should’ve been given more. Further research into a retest comparing a higher level of THC in the marijuana cigarette versus the traditional anti-emetic should be warranted. On the contrary, “Orr, McKernan, and Bloome (1980) compared oral THC, prochlorperazine, and placebo in patients with severe CINV. The 55 patients with various malignancies who participated in the double-blind, randomized crossover study were receiving chemotherapies of moderate to very high emetic potentials” (Cotter p. 349). The medicine was administered before chemotherapy, and afterwards the patients rated their nausea within 24 hours of receiving the drug. This study concluded that, “Oral THC was significantly more effective in controlling CINV with moderately to highly emetogenic (vomit inducing) chemotherapies. A staggering 73% of patients who took the THC pill experienced complete nausea relief, while 15% saw relief through the prochlorperazine, and 9% saw relief with the placebo (Cotter p. 347). In this case, the cannabis had a profound effect on lessening the nausea for the patients. In this particular trial, cannabis once again provided the most substantial relief from nausea. I believe these clinical trials relate to my proposed research because if a chemotherapy patient has an adverse reaction to marijuana in any form, they can always fall back on a traditional anti- nausea medication to try and neutralize their nausea. It should be noted, however, that these traditional anti-emetics such as thiethylperazine have an extensive list of possible side effects to include, “dryness of the mouth and nose, blurred vision, tremor, weight gain, incontinence, and fever” ("Torecan (thiethylperazine)," 2014). The noted side effects from cannabis were sleepiness, sore throat, or a headache (Musty & Rossi, 2001).
  • 7. NAUSEA RELIEVING PROPERTIES OF CANNABIS 7 A patient may want to weigh each option and determine if their relief from nausea is more important than side effects from either traditional anti-emetics or cannabis. Cannabis versus placebo: In the interest of exploring how chemotherapy patients perceive nausea, various trials have been done to test marijuana versus a placebo. It is important to remember that just like pain, nausea can be subjective. In 1979, Frytak et al. compared prochlorperazine, THC and placebo to treat CINV. 116 patients with GI cancer were given THC, placebo or the traditional anti-emetic two hours prior to chemo. According to Cotter, “Treatment effects, including nausea and vomiting, sedation, coordination, and feelings of being “high” were evaluated by participant interviews” (p. 349). This study is quite similar to the one done by Orr, McKernan, and Bloome, because the same substances were tested. The difference was that in the study by Frytek, “No statistically significant difference was observed between THC and prochlorperazine in regard to their antiemetic properties” (Cotter p. 349). But in both studies, the placebo provided relief to a miniscule amount of people. As with any placebo, there is the possibility that those patients thought they were receiving a real medication, whether it be THC or traditional, and their brains convinced themselves that the nausea was gone. As previously mentioned, nausea is a subjective experience. I believe this related to my proposed research because the research I am proposing focuses on relieving chemotherapy induced nausea, and these studies made it clear that cannabis in any form helped reduce their nausea. My research also seeks to find out the best way for chemotherapy patients to find relief. If Frytek found no apparent difference in relief between cannabis and traditional medicine, it would be worth a more current retrial.
  • 8. NAUSEA RELIEVING PROPERTIES OF CANNABIS 8 New forms of cannabis: A new synthetic THC pill called Namisol has been only tested once in clinical trials, but the research aims to evaluate how quickly a patient can receive relief from CINV, and how effective it can be. The aim for this new drug Namisol, is to harness the most pure form of THC in a pill, and have it be working for the patient in a small amount of time. In 2011, Klumpers & Beumer, et al published a study involving the most efficient administration of Namisol in humans. The authors note how, “This is a first in human trial investigating the optimal administration route of Namisol, the safety, pharmacokinetics, pharmacodynamics and tolerability” (Klumpers & Beumer, et al 2012, p. 43). Since the pill is so new, the first tests aim to find the quickest onset as well as effectiveness versus the other synthetic THC pills. According to Klumpers and Beumer, et al, “Namisol is well-tolerated and absorbed quickly after ingestion, and reaches peak plasma concentrations within 1 h and maximal effects between 1 to 2 h after administration. Compared with the literature on registered dronabinol formulations and cannabis based medicines, these results imply that Namisol may also have favorable pharmacokinetic and pharmacodynamic characteristics in patients” (Klumpers & Beumer et al 2012). Suggestions for further research include more trials with Namisol compared to traditional THC pills, and Namisol against smoked marijuana. There could also be further studies conducted on when Namisol should be administered to achieve nausea relief the fastest, whether it is an hour before chemotherapy, or right after chemotherapy. I believe this is related to my research proposal because the aim is to find out how chemotherapy patients can find relief from nausea through cannabis. Namisol could very well be the most pure and efficient THC pill to administer to chemotherapy patients who have an aversion to smoking cannabis. My data that I gather will examine the best ways
  • 9. NAUSEA RELIEVING PROPERTIES OF CANNABIS 9 to relieve cannabis, and find out through a survey what types of cannabis have been utilized. Merging the traditional and alternative: A chemotherapy patient should not be limited in their regime to find relief from nausea. If the possibility exists to merge traditional anti-nausea medicines with a synthetic THC oral spray, that option deserves to be on the table for chemotherapy patients. In 2009, Duran et al. ran a, “pilot, randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate the tolerability of an acute dose titration of Sativex (oral spray), containing THC and cannabidiol, taken in conjunction with standard therapies in the control of CINV” (Duran, et al 2009). Cotter (2009) analyzes how, “ The addition of the cannabinoids to existing antiemetic regimens may provide increased relief of CINV, resulting in better quality of life and overall health of patients with cancer” (p. 351). The idea to mix medicinal cannabis and traditional regimes is a relatively new idea, since this study was only published 4 years ago. Further trials should be warranted to see if the combination of anti emetics and Sativex could be the best way to treat chemotherapy induced nausea and vomiting. The question still remains of what treatment is ultimately best for CINV. As more research is compiled on the medicinal benefits of cannabis for chemotherapy patients, perhaps the most fruitful mixture of medicines will help these people find relief without unpleasant side effects. I believe this is related to my research because finding the best relief from nausea is the ultimate goal for chemotherapy patients. If a medicine such as Sativex could provide the quickest relief, with the least amount of side effects, this should be the first treatment option available for chemotherapy patients by doctors. My research may also find that the oral spray is the easiest to administer to chemotherapy
  • 10. NAUSEA RELIEVING PROPERTIES OF CANNABIS 10 patients who don’t like to smoke or can’t stand to swallow a pill due to their nausea. But the further testing and data analysis would need to be provided to back up the argument in favor of Sativex. If a fast acting, absolute relief from nausea can be created, society can continue its circle of healthy functioning through healthier chemotherapy patients, who contribute to a well-balanced society. Theoretical Foundations The theory I chose that meshes best with my research question is the functionalist theory by Emile Durkheim. According to Functionalism, “Each aspect of society is interdependent and contributes to society's functioning as a whole. If all goes well, the parts of society produce order, stability, and productivity” (“Three major perspectives”, 2014). Since my research revolves around getting through chemotherapy in the most comfortable way possible, it’s focused on people who are sick. In Durkheim’s theory, he speaks of how society is a product of all the parts. If a part of society (people with cancer) is sick, the natural order is to make them well again. It’s just like if someone’s leg is broken, they can’t function to their fullest potential until the leg heals. Someone who has constant nausea may not be able to eat, and if they can’t eat, they can’t thrive and get well again. If they take cannabis and decrease or get rid of their nausea, and they can eat, and then they can push through the chemotherapy and get well again. Once well, these once sickly people can now contribute to the greater society, and help be productive members of that society. Someone who had a profound experience during their chemotherapy may just end up helping others, or spreading around information about how they made it through. If cannabis can be at the forefront of treatment for
  • 11. NAUSEA RELIEVING PROPERTIES OF CANNABIS 11 chemotherapy induced nausea, then others can potentially find relief sooner, and get through chemotherapy with less misery, and reach their full potential quicker. Another supporter of Functionalism was Talcott Parsons. He believed that, “Society is the way it is as social structures are interconnected and dependent on each other” (Bryant, 2011). Even though people with chemotherapy are sick, they are still contributing to the productivity of society by giving doctors, nurses, nutritionists, and medical staff jobs. They are spurring more research into proposals like mine, and making the rest of the healthy world look more into cancer and the relief from unpleasant chemotherapy side effects. On the surface, chemotherapy patients may seem like a burden on a society, when in reality society needs the ill as much as the ill need people to make them well again. Methodology and Research Methods The research I’m proposing is to find out if cannabis lessens nausea in chemotherapy patients. The independent variable is cannabis use, and the dependent variable is level of nausea. Cannabis use is defined as smoking a marijuana cigarette, using THC oil, using a THC Oral Spray, eating foods/drinks infused with THC, (brownies, cookies, tea), or inhaling vapor. Nausea is defined as feeling like one has to throw up. To measure if nausea was relieved, the survey will have a scale of Poorly (Felt nauseous frequently), Acceptably (Minimal Nausea), Very Well (Nausea maybe once a day), and Completely knocked out Nausea. The research I conduct will be quantitative, because it is a survey that serves to measure effectiveness against nausea and effectiveness of cannabis. The respondents must have had chemotherapy at one point in their life, which may or may not be indicative of having cancer. But usually, people go
  • 12. NAUSEA RELIEVING PROPERTIES OF CANNABIS 12 through chemotherapy to lessen the size of their tumors, and to try and stop cancer from getting progressively worse. As I learned through my pilot study, some people go through chemotherapy for other reasons and diseases, like lupus. Participants I intend to have a sample size of roughly 200 chemotherapy patients, from all around California. I will accept people of all races and ethnicities, any age, any profession, and at any stage of chemotherapy. If someone had chemotherapy 6 years ago, his or her opinions are still valid. I chose a sample size of 200 because that seems to be the average size I’ve researched about, and those results were the ones published. Also, a sample size that large would produce results that were statistically significant. Instrument My instrument is a 10- question survey. I will take what I learned in the pilot study and vary the questions accordingly. I will explain each question, and its attributes. Question 1: What is your gender? The attributes are: Male and Female. This is the only type of demographic information I require, since the research is about whether or not cannabis helps relieve nausea in chemotherapy patients. I am not concerned if their ethnicity relates to their cannabis helping with the nausea. Question 2: What stage of cancer did you have at your diagnosis? Attributes: Stage 0 (Stage 0 cancers are still located in the place they started and have not invaded nearby tissues. This stage of cancer is often highly curable, usually by removing the entire tumor with surgery); Stage I (This is usually a small cancer or tumor that has not grown deeply into nearby tissues and has not spread to the lymph nodes or other parts of the body); Stage II (These stages indicate cancers or tumors that are larger in size, have grown more deeply into nearby tissue, and
  • 13. NAUSEA RELIEVING PROPERTIES OF CANNABIS 13 have spread to lymph nodes, but not to other parts of the body.); Stage III; and Stage IV (cancer has spread to other organs or parts of the body. It may also be called advanced or metastatic cancer.) I will have a last option as: Had non-cancer diagnosis. This will cover anyone who had another disease. Question 3: What type of chemotherapy drugs did doctors give you to fight your cancer? The attributes are as follows: Alkylating agents, Antimetabolites, Anti-tumor antibiotics, Topoisomerase or Mitotic inhibitors, Corticosteroids, Miscellaneous chemo drugs, or other. I am not going to list out examples of each, since there are hundreds of types of drugs. If a person is unsure of what class their drugs are in, they can ask their doctor. I will make this question one that the respondent can select multiple answers, if they’re on a regime of multiple drugs. Question 4: What level of emetogenicity (vomit inducing potential) were your chemo drugs? The attributes are: High, Moderate, Minimal, or Unsure. Question 5: Which anti- emetic drugs (effective against nausea and vomiting) did you try? The attributes are: None, Traditional, Steroids, Dopamine Antagonists, or Other. The other option will be open ended, so the respondent can fill in their medicines. Question 6: What type of cannabis did you use to control your nausea? The attributes are: None, Marijuana Cigarette, THC Oil, Oral Spray, Edibles, or Vapor. This question will have the option to select multiple answers. Question 7: How well did traditional medicines conquer your nausea from chemo? The attributes are: Never used traditional medicines, Poorly (Felt nauseous frequently), Acceptably (Minimal nausea), Very Well (Nausea maybe once a day), and Completely knocked out my nausea. Question 8: How well did Cannabis conquer your nausea from chemo? Attributes: Never used cannabis, Poorly (Felt nauseous frequently), Acceptably (Minimal nausea), Very Well (Nausea maybe once a
  • 14. NAUSEA RELIEVING PROPERTIES OF CANNABIS 14 day), and Completely knocked out my nausea. Question 9: If you have never used cannabis to control your nausea from chemotherapy, would you try it? Attributes: Yes, No, Not Applicable. Question 10: How important was relieving your nausea during chemotherapy? Attributes: Not important, A little bit important, Very important, and A matter of eating or not eating for me. These are all the survey questions, with some being only answerable with one choice, and others have the option of choosing multiple answers. Procedures My procedure for the large-scale survey are to seek out chemotherapy patients, make a quality survey, give the patients the survey via mail, in person, and on the internet, and try and get responses in a timely manner. This survey, when administered online, will only be send to the intended recipients. Getting people to participate in the survey requires contacting them in some way, through email, telephone, or physically going to the cancer treatment center. Another way of initial contact, as used in the pilot study, is to post on an online forum my plan for the survey, and see who responds. Since this is a California-wide survey, I could only drive locally. I would have to telephone or email everyone else. The people who have the survey emailed to them will be able to return it quicker, so email may be the best way to save money and disperse surveys in a quick manner. Those who have a hard-copy survey may take more time to respond, due to the mail system. Also, a consent form needs to be drafted and dispersed, so the respondents understand that the survey is completely anonymous and confidential, and will only be used in my SSCU 494 class. Once all surveys have been dispersed, there will
  • 15. NAUSEA RELIEVING PROPERTIES OF CANNABIS 15 be a waiting period of about one to two months to receive back all data and start analyzing it. I will explore the data for trends and patterns, and see if the results from the pilot study matched results from the larger study. Limitations Just with any research method, surveys have limitations. There is a potential for bias from people who are pro-cannabis before they were diagnosed with chemotherapy, and the people who have been avid smokers before they needed it medically. Also, people who have no Internet, or are not well enough to complete a survey would not be able to be reached. Also, it is worth mentioning that different ethnicities relate to subjective events like nausea, perhaps differently. One person may perceive a quick wave of nausea as extreme, while another person may see that as mild. Last, the cost to print out, mail, then pick up hundreds of surveys may prove an issue. Anticipated Findings My research begged the question: Does cannabis use decrease nausea in chemotherapy patients? Through my research and my pilot study, the data indicates that cannabis helps a majority of either surveyed or tested chemotherapy patients reduce or eliminate their nausea after chemotherapy. Therefore, I reject the null hypothesis that states: Cannabis use does not decrease nausea in chemotherapy patients. I expect my research to reveal three major findings. The first finding I expect is that cannabis will help decrease chemotherapy patient’s nausea very well after chemotherapy. Very well is defined as having nausea perhaps once a day. In some results
  • 16. NAUSEA RELIEVING PROPERTIES OF CANNABIS 16 from my pilot study, out of 13 patients, 53.85% reported that cannabis conquered their nausea very well after chemotherapy. In lieu of this, I expect these results to be similar in a larger study. These patients turned to a variety of types of cannabis through different routes, but the relief came to all but a few patients. Overall, at least 84.61% of patients who used cannabis saw at least an acceptable amount of relief (minimal nausea) or better after their chemotherapy. This insinuates that cannabis is an effective reliever of nausea for some people. The second finding I expect to see is that chemotherapy patients will most likely turn to cannabis if their traditional anti-nausea medicines fail. I expect these findings to also be evident in the larger study that would be completed. The Institute of Medicine published in its Mar. 1999 report titled "Marijuana and Medicine: Assessing the Science Base":" It is possible that the harmful effects of smoking marijuana for a limited period of time might be outweighed by the antiemetic benefits of marijuana, at least for patients for whom standard antiemetic therapy is ineffective and who suffer from debilitating emesis" (J. Joy, S. Watson, Jr. & J. Benson, Jr. (Eds.), 1999). For some patients, traditional medicines fail, and they must find alternatives to deal with their nausea. Cannabis can be that alternative. Also, according to information from my pilot study, 53% of chemotherapy patients answered that their traditional anti-nausea medication provided poor relief from nausea. Poor relief is defined as still feeling nauseous frequently. The third finding I expect is to see that overall, cannabis has provided chemotherapy patients with more relief, and a better life due to them being able to relieve their nausea. If a chemotherapy patient’s nausea is conquered, they can get back into their
  • 17. NAUSEA RELIEVING PROPERTIES OF CANNABIS 17 regular workflow and be a functioning member of society again. Kate Scannell, MD, Co- Director of the Kaiser-Permanente Northern California Ethics Department, wrote the following in the Feb. 16, 2003 article "Mr. Attorney General, Listen to the Doctors" published in the San Francisco Chronicle: "I knew this woman was dying a prolonged and miserable death. And, from years of clinical experience, I - like many other doctors - also knew that marijuana could actually help her. From working with AIDS and cancer patients, I repeatedly saw how marijuana could ameliorate a patient's debilitating fatigue, restore appetite, diminish pain, remedy nausea, cure vomiting and curtail down-to-the bone weight loss. I could firmly attest to its benefits and wager the likelihood that it would decrease her suffering." (Scannell, 2003). As Dr. Scannell and hundreds of others understand, cannabis can truly help people who need to restore balance back in their lives, and finally feel some relief that they deserve. Conclusion with Policy Recommendations I delved into this research with the intentions to seek out the most effective and natural way for chemotherapy patients to find relief from their nausea. Having relief from nausea not only means feeling better, but it also allows the patient to eat normally, and have a better overall health, given their circumstances. Some gaps in my research still exist, such as finding out which combination of medicine will work best. This could either be synthetic and natural cannabis; or it could be a mixture of a traditional anti- emetic and cannabis. More clinical trials will need to be completed in that arena, in addition to more focus on the new up and coming THC pills on the market. Next, a gap in my research is delving in to the arena of whether or not cannabis and cannabinoids
  • 18. NAUSEA RELIEVING PROPERTIES OF CANNABIS 18 should be on the front line of defense for chemotherapy induced nausea, instead of other traditional anti-emetics. The future will hold the key to finding out the quickest, most natural and helpful relief for these suffering from chemotherapy induced nausea. Perhaps with further research, lives can be improved sooner. Even though a cancer diagnosis seems bleak, it is all part of the overall function of a healthy society. I would send this research proposal to Oncologists around the country, as well as the American Cancer Society, and policy makers in Washington in an effort to make a change in the procedure of certain policies. The policy change I would like to see is to have cannabis at the forefront of nausea relief, and the first line of defense, instead of an alternative medicine. The goal is to benefit the suffering community of cancer patients who deserve relief from their nausea.
  • 19. NAUSEA RELIEVING PROPERTIES OF CANNABIS 19 APPENDIX I Item 1 (GENDER) What is your gender? 1= Male; 2= Female Item 2 (STAGE) What stage of cancer did you have at your diagnosis? 1= Stage 0 (Stage 0 cancers are still located in the place they started and have not invaded nearby tissues. This stage of cancer is often highly curable, usually by removing the entire tumor with surgery) 2= Stage I (This is usually a small cancer or tumor that has not grown deeply into nearby tissues and has not spread to the lymph nodes or other parts of the body) ; 3= Stage II (II & III) These stages indicate cancers or tumors that are larger in size, have grown more deeply into nearby tissue, and have spread to lymph nodes, but not to other parts of the body.) ; 4= Stage III; 5= Stage IV (cancer has spread to other organs or parts of the body. It may also be called advanced or metastatic cancer.) Item 3 (CHEMOMED) What type of chemotherapy drugs did doctors give you to fight your cancer? 1= Alkylating agents; 2= Antimetabolites; 3= Anti-tumor antibiotics; 4= Topoisomerase or Mitotic inhibitors; 5= Corticosteroids ; 6= Miscellaneous chemo drugs; 7= Other (Differentiating agents, hormone therapy, immunotherapy) Item 4 (STRENGTH) What level of emetogenicity (vomit inducing potential) were your chemo drugs? 1= high emetogenic potential; 2= moderately emetogenic potential; 3= minimal emetogenic potential; 4= Unsure Item 5 (CINV) Which anti-emetic drugs did you try? 1= None; 2= Traditional (Anzemet, Kytril, Zofran, Aloxi,); 3= Steroids (Decadron, Medrol,); 4= Dopamine Antagonists (Inapsine, Haldol, Reglan, Compazine, Phenergan); 5= Other Item 6 (CANNABIS) What type of cannabis did you use to control your nausea? 1= None; 2= Marijuana cigarette; 3= THC Oil; 4= THC Oral-mucosal spray; 5= Marijuana in anything edible; 6= Synthetic THC Pill (Marinol, Cesamet, Namisol), 7= Vapor Item 7 (TRADITION) How well did traditional anti-emetics conquer your nausea from chemo? 1= Never used traditional; 2= Poorly (Felt nauseous frequently); 3= Acceptably (Minimal nausea); 4= Very Well (Nausea maybe once a day); 5= Completely knocked out my nausea
  • 20. NAUSEA RELIEVING PROPERTIES OF CANNABIS 20 Item 8 (CANNACUR) How well did cannabis conquer your CINV? 1= Never used cannabis; 2= Poorly (Felt nauseous frequently); 3= Acceptably (Minimal nausea); 4= Very Well (Nausea maybe once a day); 5= Completely knocked out my nausea Item 9 (NEVER) If you never used cannabis to control your nausea from chemotherapy, would you try it? 1= yes; 2=No; 3= Not Applicable Item 10 (IMPORTAN) How important was relieving your nausea during chemotherapy? 1= Not important; 2= A little bit important 3= Very important 4= A matter of eating or not eating for me
  • 21. NAUSEA RELIEVING PROPERTIES OF CANNABIS 21 APPENDIX II Please read this consent agreement carefully before you decide to participate in the survey. Project Title: An Investigation of the Nausea Relieving Properties of Cannabis for Chemotherapy Patients Researcher: Sarah Hooks, Brandman University, Fairfield CA The purpose of this research study is to understand if cannabis can relieve nausea in chemotherapy patients. In this study you will be asked to complete 10 survey questions, and if given a hardcopy study, mail it back to Sarah Hooks. Risks: There is a slight risk that this study may make you upset. If it does, you may quit at any time. Benefits: There are no guaranteed benefits to you for participating in this research study. You will receive no payment for participating in this study. Confidentiality: The information that you give in the study will be handled confidentially. The information you provide will not be linked back to you. Your participation in the study is completely voluntary. You have the right to withdraw from the study at any time without penalty. If you have questions about the study, contact: Sarah Hooks, shooks@mail.brandman.edu If you have questions about your rights in the study, contact: Professor Nancy Brown
  • 22. NAUSEA RELIEVING PROPERTIES OF CANNABIS 22 References: 2007 weight loss. (2007, JAN). Men's Health, 135. Retrieved from http://books.google.com/books?id=0scDAAAAMBAJ&pg=PA135&lpg=PA 135&dq=We have two options, medically and emotionally: give up or fight like hell&source=bl&ots=lxzMEQypR7&sig=4wdp3QNSM8_W5YyOGJ- JJiM7UdY&hl=en&sa=X&ei=jOB1U7eUK4LvoAS54YCIBQ&ved=0CD4Q6 AEwBjgK American Cancer Society. Cancer Facts & Figures 2014. Atlanta: American Cancer Society; 2014. Cancer statistics by cancer type. (2013, SEP 25). Retrieved from http://www.cdc.gov/cancer/dcpc/data/types.htm Cannabis. (2014, MAY 15). Retrieved from http://www.merriam webster.com/dictionary/cannabis Chemotherapy. (2014, MAY 15). Retrieved from http://www.merriam- webster.com/dictionary/chemotherapy Chemotherapy-induced nausea and vomiting (cinv). (2014, JAN 27). Retrieved from http://www.myvmc.com/symptoms/chemotherapy-induced-nausea- and-vomiting-cinv/ Cotter, J. (2009). Efficacy of crude marijuana and synthetic Delta-9- Tetrahydrocannabinol as treatment for chemotherapy-induced nausea and vomiting: a systematic literature review. Oncology Nursing Forum, 36(3), 345- 352. doi:10.1188/09.ONF.345-352 This researcher set out to compare how cancer patients felt when smoking “crude” cannabis versus taking a synthetic form of THC to help with their chemotherapy induced nausea and vomiting (CINV). This article is a summation of research on 10 clinical trials found through MEDLINE, CINAHL and Cochrane Library. The 10 studies (usually randomized, crossover, double blind; although some not randomized, with most having placebo) had anywhere from 15- 214 chemotherapy patients, who either took a synthetic THC pill, smoked a marijuana cigarette, took a traditional anti-emetic drug, or had a placebo. The main conclusion was that the synthetic THC pill and crude marijuana were highly effective in reducing nausea and vomiting, whereas the placebo did not help reduce vomiting. In some studies, both the traditional anti-emetic drug and THC both provided relief from nausea and vomiting. This article applies to my research proposal because it helps me understand just how helpful THC (cannabis) is for cancer patients with nausea and vomiting. There are, however, drawbacks for using the THC pills/ smoking: it seems there may be side effects of feeling high and coordination decreasing. Future research into the benefits of combining a traditional anti-emetic drug with a THC pill could prove to be the most effective treatment for CINV.
  • 23. NAUSEA RELIEVING PROPERTIES OF CANNABIS 23 Duran, M., Pérez, E., Abanades, S., Vidal, X., Saura, C., Majem, M., & ... Capellà, D. (2010). Preliminary efficacy and safety of an oromucosal standardized cannabis extract in chemotherapy-induced nausea and vomiting. British Journal Of Clinical Pharmacology, 70(5), 656-663. doi:10.1111/j.1365-2125.2010.03743.x Frytak, S., Moertel, C.G., O’Fallon, J.R., Rubin, J., Creagan, E.T., O’Connell, M.J., et al. (1979). Delta-9-tetrahydrocannabinol as an antiemetic for patients receiving cancer chemotherapy. A comparison with prochlorperazine and a placebo. Annals of Internal Medicine, 91(6), 825–830. Klumpers, L. E., Beumer, T. L., van Hasselt, J. C., Lipplaa, A., Karger, L. B., Kleinloog, H., & ... van Gerven, J. A. (2012). Novel Δ9-tetrahydrocannabinol formulation Namisol® has beneficial pharmacokinetics and promising pharmacodynamic effects. British Journal Of Clinical Pharmacology, 74(1), 42-53. doi:10.1111/j.1365-2125.2012.04164.x This article aims to measure the effects of a new THC tablet called Namisol, and how quickly it is absorbed into the human body compared with the other two synthetic cannabis drugs. The study was conducted with two panels of tests. The first panel was to determine the most favorable administration route either oral or sublingual (under the tongue), using 12 people (6 male and 6 female), in a double blind, double dummy, two- way crossover study. The second panel, to determine how different doses affect the human body, utilized 9 people of mixed gender in a randomized, double blind, placebo controlled trial. The people were between the ages of 18 to 55, and had a BMI between 18- 28 kg m. They had to have used cannabis for a year before the study. The main finding of the panels were that Namisol was more effective when administered orally, compared with sublingually (under the tongue). The dosage panels all experienced dizziness as an adverse side effect, with doses of 8.0 mg THC, 6.5 mg THC, and placebo. Also, all non-placebo groups felt euphoric. This study relates to my proposal because it sheds light on the fast acting nature of this new THC tablet Namisol compared with Nabilone, another synthetic THC pill. This could be useful for chemotherapy patients who need quick relief, and who don’t want to smoke cannabis. Future research on more clinical trials with Namisol is needed to be able to sufficiently say it is the best synthetic form of THC on the market. Marijuana and medicine: Assessing the science base. In (1999). J. Joy, S. Watson, Jr. & J. Benson, Jr. (Eds.), Washington, D.C: NATIONAL ACADEMY PRESS. Retrieved from http://medicalmarijuana.procon.org/sourcefiles/IOM_Report.pdf Musty, R., & Rossi, R. (2001). Effects of smoked cannabis and oral delta9- tetrahydrocannabinol on nausea and emesis after cancer chemotherapy: a review of state clinical trials. Journal Of Cannabis Therapeutics, 1(1), 29-42.
  • 24. NAUSEA RELIEVING PROPERTIES OF CANNABIS 24 Orr, L.E., McKernan, J.F., & Bloome, B. (1980). Antiemetic effect of tetrahydrocannabinol. Compared with placebo and prochlorperazine in chemotherapy-associated nausea and emesis. Archives of Internal Medicine, 140(11), 1431–1433. Rocha, F., Stefano, S. C., Haiek, R., Oliveira, L., & Da Silveira, D. X. (2008). Therapeutic use of Cannabis sativa on chemotherapy-induced nausea and vomiting among cancer patients: systematic review and meta-analysis. European Journal Of Cancer Care, (5), 431. doi:10.1111/j.1365- 2354.2008.00917.x The main research question of this summation of studies was whether or not cannabinoids can help with chemotherapy patients and their nausea and vomiting. This article covered a multitude of studies; the various research methods included randomized, crossover, parallel, paired, and double blind studies. Most studies focused on cancer patients both young and old. All patients either had a form of cancer (lung) or a type of tumor (carcinoma, sarcoma, breast, ovary). The main finding was that the cannabinoids helped greatly with nausea and vomiting compared to regular drugs. However, the cannabinoids also produced more side effects than regular drugs. Some side effects were pleasant, while others were unpleasant. This article relates to my study because it sheds light on my inquiry about if cannabis can help with nausea in chemo patients. Some suggestions for future research are further clinical trials testing cannabinoids and modern medicines, to gain further data. Scannell, K. (2003, FEB 16). Medical marijuana / Mr. attorney general, listen to the doctors and patients / john Ashcroft, meet a cancer victim. San Francisco Chronicle. Retrieved from http://www.sfchronicle.com/opinion/article/MEDICAL-MARIJUANA-Mr- Attorney-General-Listen-2669856.php Walsh D., Nelson K.A. & Mahmoud F.A. (2003) Established and potential therapeutic applications of cannabinoids in oncology. Support Care Cancer 11, 137–143.