Cannabics Capsules as Treatment to Improve Cancer Related CACS in Advanced Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02359123|
Recruitment Status : Recruiting
First Posted : February 9, 2015
Last Update Posted : August 3, 2017
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.
|Condition or disease||Intervention/treatment|
|Cancer Cachexia Atypical Anorexia Nervosa||Other: Cannabics capsules|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cannabics Capsules as Treatment to Improve Cancer Related Cachexia and Anorexia Syndrome in Advanced Cancer Patients- Pilot Study|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||April 2018|
Experimental: Cannabics 5mg
Patients will be treated initially for 3-4 days with 1x5mg Cannabics capsules per day for gradual adaptation. From the 5th day, patients will be treated 2x5mg capsules per 24 hours for a period of 3 months. However, since some patients may suffer from side effects mainly, dizziness and or anxiety, dosage for these patients will be reduced to 5mg per day.
Other: Cannabics capsules
Cannabis extract in an oil formulation
Other Name: Cannabics SR
- weight gain of ≥10% from baseline weight assessed. [ Time Frame: 3 months ]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
- Improvement in appetite [ Time Frame: 3 months ]measured by [include analysis, scale, questionnaire, etc.]
- Nutritional intake [ Time Frame: 3 months ]evaluation on the first week and after three months, based on daily caloric calculation of three day food diary.
- Reduction in TNF-alpha [ Time Frame: 3 months ]level assessed by CBC, biochemistry blood test, TNF-alpha level on day 1, and after three months
- Correlation between THC levels and primary outcome, [ Time Frame: 3 months ]assessment by Urine THC- levels one day 1, 2 weeks, 3 months.
- 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. [ Time Frame: 3 months ]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.
- Safety assessment for early psychiatric side-effects by the Community Assessment of Psychic Experiences [ Time Frame: 3 months ](CAPE) questionnaire on day 1 and after 2 weeks and after 3 months.
- Evaluation of muscle strength [ Time Frame: 3 months ]using hand dynamometer as estimation for muscle mass on day 1 and after three months.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359123
|Contact: Eyal Ballan, Ph.Demail@example.com|
|Contact: Gil Bar-Sela, MDfirstname.lastname@example.org|
|Principal Investigator:||Gil Bar-Sela, Md||Rambam MC|