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Cannabics Capsules as Treatment to Improve Cancer Related CACS in Advanced Cancer Patients

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ClinicalTrials.gov Identifier: NCT02359123
Recruitment Status : Completed
First Posted : February 9, 2015
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Cannabics Pharmaceuticals Inc.

Brief Summary:

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 Phase
Cancer Cachexia Atypical Anorexia Nervosa Other: Cannabics capsules Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Improvement in appetite [ Time Frame: 3 months ]
    measured by [include analysis, scale, questionnaire, etc.]

  2. 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.

  3. 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

  4. Correlation between THC levels and primary outcome, [ Time Frame: 3 months ]
    assessment by Urine THC- levels one day 1, 2 weeks, 3 months.

  5. 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.

  6. 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.

  7. Evaluation of muscle strength [ Time Frame: 3 months ]
    using hand dynamometer as estimation for muscle mass on day 1 and after three months.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359123


Locations
Israel
Rambam MC
Haifa, Israel
Sponsors and Collaborators
Cannabics Pharmaceuticals Inc.
Investigators
Principal Investigator: Gil Bar-Sela, Md Rambam MC

Responsible Party: Cannabics Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02359123     History of Changes
Other Study ID Numbers: CNBX-001
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Cachexia
Wasting Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders