Cancer Cachexia Clinical Trial
Official title:
Cannabics Capsules as Treatment to Improve Cancer Related Cachexia and Anorexia Syndrome in Advanced Cancer Patients- Pilot Study
The main purpose in the treatment of patients with advanced cancer and cancer anorexia
cachexia syndrome (CACS) is to prolong life and to improve quality of life (QoL) as far as
possible. QoL in patients with CACS is directly related to loss of appetite and loss of
weight. Cannabis pills are given in Israel to advanced cancer patients with various symptoms
in order to improve their QoL. There is data on safety/toxicity of cannabis, and these pills
are given under the regulations of the Israel Ministry of Health.
The purpose of this study is to examine the influence of Cannabics capsules on improving loss
of appetite and loss of weight.
Cannabis has long been suggested to stimulate appetite, decrease nausea and vomiting, and
improve quality of life in cancer patients. Studies on the efficacy of cannabis for improving
CACS and S-NIS have had mixed results. After trials showing improvement in weight gain among
AIDS patients, cannabinoids were tested on cancer patients as well. In a controlled, random
study comparing dronabinol to a placebo among cancer patients, dronabinol was associated with
increased appetite in 38% vs 8% for placebo, and decreased nausea in 20% vs 7%, using
acceptable measurement scales. Of the dronabinol patients, 22% gained ≥2 kg, compared with
10.5% of placebo recipients, but this datum did not reach significance, perhaps due to the
advanced stage of cancer and the high mortality in both placebo and experimental group (30).
Another randomized study compared dronabinol to megestrol acetate or both treatments
together. The research included 469 advanced cancer patients who had been suffering from a
substantial appetite loss. A greater percentage of megestrol acetate-treated patients
reported appetite improvement compared with dronabinol-treated patients, 75% vs 49%
(p=0.0001). Combination treatment resulted in no significant differences compared with
megestrol acetate alone. Another study, which included 243 patients, compared the
administration of a combination of tetrahydrocannabinol and cannabinol to
tetrahydrocannabinol alone, compared to placebo. It should be noted that cannabinoid dosages
in the study were low, even in comparison to other studies. No significant differences
between the groups were seen regarding improvement in appetite or weight-gain. In these two
studies, no substantial side effects of cannabis products were found compared to the other
arms. This may be related to the dosages of the drugs given.
A more recent study demonstrated improved chemosensory perception, appetite, sleep, and
macronutrient preference in advanced cancer patients. However, the study included less than
50 patients. This research showed improvement in taste and smell perception in patients
receiving chemotherapy, as well as appetite and caloric intake in the arm that received
dronabinol compared to placebo.
Assessment: Base-line assessment
1. Physician anamnesis and physical examination
2. Complete blood cell count (CBC) and biochemistry test: electrolytes, renal and liver
function tests, albumin level, total cholesterol level
3. Blood test for TNF-alpha level
4. Nutrition evaluation, including daily caloric calculation (by using 3 day food diary)
and weighting the patient
5. QoL assessment by EORTC C30 and Anorexia/Cachexia Therapy assessment by FAACT
questionnaire
6. Evaluation of muscle strength by using hand dynamometer as estimation for muscle mass.
Treatment assessment
1. Physician anamnesis including toxicity assessment according to CTCAE recommendations for
acute toxicity, and physical examination including weighing the patient every two weeks
in the first month, every month in the coming two months, and every six weeks in the
next three months
2. CBC, biochemistry blood test, TNF-alpha level on day 1, and after three months
3. Nutritional intake evaluation on the first week and after three months, based on daily
caloric calculation of three day food diary
4. Muscle strength evaluation on day 1 and after three months
5. QOL assessment by EORTC C30 and Anorexia/Cachexia Therapy assessment by FAACT
questionnaire on day 1 and after three and six months
6. Safety assessment for early psychiatric side-effects by the Community Assessment of
Psychic Experiences (CAPE) questionnaire on day 1 and after 2 weeks and after 3 months.
7. Urine THC- levels one day 1, 2 weeks, 3 months.
Quality-of-Life (QOL) Assessment
QOL will be assessed using the European Organization of Research and Treatment of Cancer core
questions on the Quality of Life Questionnaire, version 2 (QLQ-C30) (43) and the
Anorexia/Cachexia Therapy (FAACT) questionnaire (44).
Nutrition assessment
1. Daily caloric calculation will be based on the three day food diary. On day 1, the
patient will meet the dietitian and receive guidance and instruction of how to complete
the diary. The cannabis pills will be given on day 4, after bringing back the three day
diary. After three months, the patient will again do a three day food diary and caloric
calculation will be made.
2. The caloric calculation will be made with the Ministry of Health Computer software
"Zameret".
3. The patient will have telephone support from the dietitian as needed during the days of
the diary completion.
4. Cannabics capsules will be given on day 4, after bringing back the three day diary.
Safety assessment:
Community Assessment of Psychic Experiences (CAPE) questionnaire to evaluated possible early
psychiatric side-effects will be given in 3 time points, together with measuring the THC
level in the urine. Evaluation of other side-effects will be done in every physician visit.
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