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Trial record 1 of 1 for:    cannabics
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Cannabics Capsules as Treatment to Improve Cancer Related CACS in Advanced Cancer Patients

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Cannabics Pharmaceuticals Inc.
Sponsor:
Information provided by (Responsible Party):
Cannabics Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT02359123
First received: January 26, 2015
Last updated: November 22, 2016
Last verified: November 2016
  Purpose

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 Intervention Phase
Cancer Cachexia Atypical Anorexia Nervosa Other: Cannabics capsules Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Cannabics Pharmaceuticals Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Improvement in appetite, as measured by ___ [include analysis, scale, questionnaire, etc.] [ Time Frame: 3 months ]
  • Nutritional intake evaluation on the first week and after three months, based on daily caloric calculation of three day food diary. [ Time Frame: 3 months ]
  • Reduction in TNF-alpha level assessed by CBC, biochemistry blood test, TNF-alpha level on day 1, and after three months [ Time Frame: 3 months ]
  • Correlation between THC levels and primary outcome, assessment by Urine THC- levels one day 1, 2 weeks, 3 months. [ Time Frame: 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 ]
  • 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. [ Time Frame: 3 months ]
  • Evaluation of muscle strength by using hand dynamometer as estimation for muscle mass on day 1 and after three months. [ Time Frame: 3 months ]

Estimated Enrollment: 40
Study Start Date: November 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02359123

Contacts
Contact: Eyal Ballan, Ph.D 972-50-8619215 eyal@cannabics.com
Contact: Gil Bar-Sela, MD g_barsela@rambam.health.gov.il

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

Responsible Party: Cannabics Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02359123     History of Changes
Other Study ID Numbers: CNBX-001
Study First Received: January 26, 2015
Last Updated: November 22, 2016

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

ClinicalTrials.gov processed this record on July 21, 2017