Cancer Cachexia Clinical Trial
Official title:
Cannabics Capsules as Treatment to Improve Cancer Related Cachexia and Anorexia Syndrome in Advanced Cancer Patients- Pilot Study
Verified date | April 2018 |
Source | Cannabics Pharmaceuticals Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | April 1, 2018 |
Est. primary completion date | April 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age above 18 years 2. Histological evidence of an incurable malignancy 3. Estimated life expectancy =3 months 4. Performance status =2 (ECOG classification) 5. Self-report of weight loss of at least 3kg during the preceding 2 months and/or a dietitian-estimated caloric intake of less than 20 calories/kg of body weight per day 6. Patient believes that loss of appetite or loss of weight is an ongoing problem for him 7. Use of chemotherapy or radiotherapy is permitted 8. Sign of written informed consent Exclusion Criteria: 1. Ongoing use of tube feedings or parental nutrition 2. Edema or ascites 3. Central nervous system metastases or brain tumors (patients with stable disease in the brain 28 days after treatment can be included in the study) 4. Treatment with adrenal corticosteroids (except for short-term dexamethasone during time of chemotherapy), androgens, progestational agents or other appetite stimulants within the previous two weeks 5. Insulin-requiring diabetes 6. Pregnancy or lactation or unwillingness to use oral contraceptives 7. Other life-threatening medical conditions 8. Anticipated alcohol or barbiturate use during the study period 9. Mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting 10. Use of cannabis or synthetic cannabinoids in the last four weeks |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam MC | Haifa |
Lead Sponsor | Collaborator |
---|---|
Cannabics Pharmaceuticals Inc. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | weight gain of =10% from baseline weight assessed. | weight gain of =10% from baseline weight assessed by 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 | 3 months | |
Secondary | Improvement in appetite | measured by [include analysis, scale, questionnaire, etc.] | 3 months | |
Secondary | Nutritional intake | evaluation on the first week and after three months, based on daily caloric calculation of three day food diary. | 3 months | |
Secondary | Reduction in TNF-alpha | level assessed by CBC, biochemistry blood test, TNF-alpha level on day 1, and after three months | 3 months | |
Secondary | Correlation between THC levels and primary outcome, | assessment by Urine THC- levels one day 1, 2 weeks, 3 months. | 3 months | |
Secondary | 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) and the Anorexia/Cachexia Therapy (FAACT) questionnaire. | 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) and the Anorexia/Cachexia Therapy (FAACT) questionnaire. | 3 months | |
Secondary | 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. | 3 months | |
Secondary | Evaluation of muscle strength | using hand dynamometer as estimation for muscle mass on day 1 and after three months. | 3 months |
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