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

NCT02359123 | Completed

• 1 other identifier: CNBX-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Cachexia; Atypical Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Improvement in appetite

  3 months

• Nutritional intake

  3 months

• Reduction in TNF-alpha

  3 months

• Correlation between THC levels and primary outcome,

  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.

  3 months

Study Arms (1)

Cannabics 5mg

EXPERIMENTAL

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

Interventions

Cannabics capsules OTHER

Cannabis extract in an oil formulation

Also known as: Cannabics SR

Cannabics 5mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years
• Histological evidence of an incurable malignancy
• Estimated life expectancy ≥3 months
• Performance status ≤2 (ECOG classification)
• 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
• Patient believes that loss of appetite or loss of weight is an ongoing problem for him
• Use of chemotherapy or radiotherapy is permitted
• Sign of written informed consent

You may not qualify if:

• Ongoing use of tube feedings or parental nutrition
• Edema or ascites
• Central nervous system metastases or brain tumors (patients with stable disease in the brain 28 days after treatment can be included in the study)
• 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
• Insulin-requiring diabetes
• Pregnancy or lactation or unwillingness to use oral contraceptives
• Other life-threatening medical conditions
• Anticipated alcohol or barbiturate use during the study period
• Mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting
• Use of cannabis or synthetic cannabinoids in the last four weeks

Sponsors & Collaborators

• Cannabics Pharmaceuticals Inc.: lead

Study Sites (1)

Rambam MC

Haifa, Israel

Location

Related Publications (1)

• Bar-Sela G, Zalman D, Semenysty V, Ballan E. The Effects of Dosage-Controlled Cannabis Capsules on Cancer-Related Cachexia and Anorexia Syndrome in Advanced Cancer Patients: Pilot Study. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419881498. doi: 10.1177/1534735419881498.

  PMID: 31595793 DERIVED

Study Officials

• Gil Bar-Sela, Md

  Rambam MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: February 9, 2015
• Study Start: November 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

IL (1)