Using cannabis to manage cancer-related symptoms

A Randomized, Double-Blind, Placebo-Controlled, Multiple Crossover N-of-1 Study Design of the Use of Medicinal Cannabis Oil-Based Extracts for Symptom Management in Cancer Patients

This study is testing different types of cannabis oil to see which one helps adults with cancer feel better by reducing pain, nausea, anxiety, and sleep problems.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: British Columbia Cancer Agency (other)
• Locations: 8 sites (Calgary, Alberta and 7 other locations)
• Trial ID: NCT03948074 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of different cannabis oil extract combinations in alleviating cancer-related symptoms such as pain, nausea, anxiety, and sleep disturbance. It employs a randomized, double-blind, N-of-1 design, where each participant will receive three types of cannabis extracts (High THC-Low CBD, Low THC-High CBD, and Equal THC/CBD) and a placebo over a series of treatment cycles. The study will include at least 120 adult participants who will be monitored for symptom relief and safety over a minimum of 16 days. The results will help determine which cannabis product is most effective for individual patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 19 and older who are experiencing distress from cancer-related symptoms or symptoms from cancer treatment.

Not a fit: Patients whose symptoms are not related to cancer or cancer treatment, or those with cannabis use disorders, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with tailored cannabis treatment options for managing distressing cancer-related symptoms.

How similar studies have performed: While there is ongoing interest in cannabis for symptom management, this specific approach using N-of-1 trials is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* At least 19 years of age;
* Competent to consent to participation in the study;
* Must have at least one of the following cancer-related symptoms or a cancer treatment-related symptoms which is causing distress: Nausea; Pain; Anxiety; Sleep Disturbance; (based on ESAS-r-SN score ≥4/10)
* Symptom(s) are expected to be stable throughout the duration of the study;
* Expecting to live for at least 4 months;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;
* Willing to commit to not taking cannabis in any form other than the study products for the duration of the study;
* Able to reliably communicate with the research team, either directly or through a translator;
* Accessible by telephone.

Exclusion Criteria:

* Their current symptoms are not related to cancer or cancer treatment;
* They have a current cannabis or other substance dependence or misuse disorder as defined by the revised Cannabis Use Disorder Identification Test (CUDIT-R) score of 8 or above;
* They admit to cannabis use for any purpose (recreational or medicinal) more than once a week during the month prior to study entry;
* They have a history of psychosis with, or other intolerance to cannabis or cannabinoids;
* They have an active psychiatric disorder likely, in the investigator's opinion, to interfere with adherence to study protocol;
* They have any concurrent condition likely to interfere with completion of the study protocol, such as allergy to any component of the study products;
* They are pregnant or planning to get pregnant or they are lactating females;
* They are women of childbearing potential (\<2 years after last menstruation) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal);
* They have reproductive potential and fail to use adequate birth control;
* They are on another clinical trial or expect to start one prior to study completion;
* They have oral disease which might impair trans-mucosal absorption, e.g. oral mucositis;
* They are taking medications that might be affected by an interaction with cannabinoids in a clinically significant manner (CYP1A1, 1A2, and 1B1) and cannot be switched to a different medication;
* They live in an environment with high risk of theft or diversion of study products;
* They have a concurrent condition that requires changes to current medications within the 48 days on study treatment.
* They have serious cardiovascular disease such as ischemic heart disease, including arrhythmias, poorly controlled hypertension, severe heart failure, recent (within 6 months) MI.
* They have first degree relatives with schizophrenia.
* They have history of epilepsy or repeated seizures or brain metastases.
* They are unable or unwilling to refrain from operating heavy machinery for the duration of their participation in this study.
* They are unable or unwilling to refrain from consuming alcohol for the duration of their participation in this study.
* They expect to leave Canada during the study period, as the study products cannot be taken across any international border (land, sea or air).

Where this trial is running

Calgary, Alberta and 7 other locations

• Tom Baker Cancer Centre — Calgary, Alberta, Canada (RECRUITING)
• BC Cancer Center of the North — Prince George, British Columbia, Canada (RECRUITING)
• BC Cancer Vancouver — Vancouver, British Columbia, Canada (RECRUITING)
• BC Cancer - Victoria — Victoria, British Columbia, Canada (RECRUITING)
• CancerCare Manitoba — Winnipeg, Manitoba, Canada (RECRUITING)
• Kingston Health Sciences Centre - Kingston General Hospital Site — Kingston, Ontario, Canada (RECRUITING)
• Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada (RECRUITING)
• Santé Cannabis — Montréal, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Philippa Hawley, FRCPC — BC Cancer
• Study coordinator: Alshanee Sharma

Conditions: Pain, Nausea, Anxiety, Sleep Disturbance