Cannabis For Cancer-Related Symptoms

NCT03948074 | Completed Phase 2 DMC

• 1 other identifier: CAFCARS
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 8

Brief Summary

Clinical evidence is urgently needed to be able to advise patients on which cannabis-based products to take, or to avoid, in managing cancer-related symptoms. This trial was therefore designed to determine which cannabis extract combination (High THC-Low CBD, Low THC-High CBD, or Equal amounts of THC and CBD) is most effective at treating cancer related symptoms for each patient relative to placebo. Investigators propose a randomized, double-blind, N-of-1 trial to test the effectiveness of each cannabis extract combination using cannabis oils in a minimum of 120 patients on 4 cancer-related symptoms: nausea, pain, anxiety and sleep disturbance. The three active treatments will be the following cannabis oil extract combinations: High THC/Low CBD, Low THC/High CBD, and Equal amounts of THC/CBD.

• THC = Tetrahydrocannabinol
• CBD = Cannabidiol The placebo treatment will be Medium Chain Triglyceride (MCT) oil. The active oils and the placebo are similar in taste, smell and effectively blind subjects. Primary objective: To identify whether there is an active cannabis extract that is more effective than placebo in managing overall cancer-related symptoms for individual subjects who completed at least 1 treatment cycle for the entire patient population represented by those individual subjects, and for subsets of that subject population defined by relevant baseline patient characteristics. Secondary objective: To identify whether there is a cannabis extract that is more effective than placebo in managing each of the 4 index symptoms (pain, nausea, anxiety and sleep disturbance) for individual subjects who completed at least 1 treatment cycle, for the entire patient population represented by those individual subjects, and for subsets of that subject population defined by relevant baseline patient characteristics. Tertiary objectives: To investigate the safety (e.g., serious adverse events) of each of the three cannabis extracts. To identify subject preference of each of the 4 oils (if any).

Conditions

Pain; Nausea; Anxiety; Sleep Disturbance

Outcome Measures

Primary Outcomes (1)

• Average Patients' Global Impression of Change (PGIC) for overall cancer-related symptoms

  The PGIC provides a single, general estimate of improvement or deterioration using scores from 1 to 7 and has been used as a research outcome indicator in a variety of contexts, particularly in chronic pain. The PGIC asks subjects to rate their current status as: 1. No change (or condition worse) 2. Almost the same (hardly any change at all) 3. A little better (no noticeable change) 4. Somewhat better (change has not made any real difference 5. Moderately better (slight but noticeable change) 6. Better (definite improvement that has made a real and worthwhile difference) 7. A great deal better and a considerable improvement that has made all the difference Subjects will be reporting their PGIC score 90 minutes after each dose of cannabis oil (1 to 6 times daily). Only scores collected on non-washout days of a treatment cycle corresponding to a particular oil formulation will be used.

  16-48 days; 90 minutes after each dose

Secondary Outcomes (1)

• Average change from baseline in the Edmonton Symptom Assessment System - revised to include Sleep Disturbance and Night Sweats (ESAS-r-SN) score

  16-48 days; once daily

Other Outcomes (1)

• Percent of subjects who prefer each study oil (Oil 1, 2, 3 or 4)

  16-48 days

Study Arms (4)

High THC/Low CBD Cannabis Oil

EXPERIMENTAL

THC+THCa = 573 mg CBD+CBDA = 0 mg Total cannabinoids = 573 mg (0.95mg/drop) Dried marijuana equivalent = 5g

Drug: Cannabis

Low THC/High CBD Cannabis Oil

EXPERIMENTAL

THC+THCa = 37mg CBD+CBDA = 784mg Total cannabinoids = 821mg (1.37mg/drop) Dried marijuana equivalent = 6g

Drug: Cannabis

Equal amounts of THC/CBD Cannabis Oil

EXPERIMENTAL

THC+THCa = 516mg CBD+CBDA = 456mg Total cannabinoids = 972mg (1.62mg/drop) Dried marijuana equivalent = 6g

Drug: Cannabis

Placebo Oil

PLACEBO COMPARATOR

Medium Chain Triglyceride (MCT) oil

Drug: Cannabis

Interventions

Cannabis DRUG

Medicinal Cannabis Oil

Also known as: Tetrahydrocannabinol, Cannabidiol

Equal amounts of THC/CBD Cannabis Oil; High THC/Low CBD Cannabis Oil; Low THC/High CBD Cannabis Oil; Placebo Oil

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pippa Hawley: lead

Study Sites (8)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

BC Cancer Center of the North

Prince George, British Columbia, V2M 7E9, Canada

Location

BC Cancer Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

Location

BC Cancer - Victoria

Victoria, British Columbia, V8R 6V5, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Kingston Health Sciences Centre - Kingston General Hospital Site

Kingston, Ontario, K7L 2V7, Canada

Location

Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Santé Cannabis

Montreal, Quebec, H3Z 2Y5, Canada

Location

MeSH Terms

Conditions

Pain; Nausea; Anxiety Disorders; Parasomnias

Interventions

nabiximols; Dronabinol; Cannabidiol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Philippa Hawley, FRCPC

  BC Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Division Head of Palliative Care

Model Details: An N-of-1 trial is a crossover trial, usually randomized and often blinded, conducted in a single patient. This type of trial provides an objective, data-driven way to determine the most effective intervention for an individual patient from among a set of competing interventions and to investigate the side-effect profiles of each intervention. It is possible to analyze the results produced by each N-of-1 trial in a series separately in order to determine whether (i) the active treatment(s) involved in the trial were effective for the corresponding patient or (ii) the novel treatment(s) involved in the trial were effective relative to the established treatment. It is also possible to aggregate the results produced by a series of simultaneous N-of-1 trials (all conducted in a similar way) using either meta-analytic methods or mixed effects modelling in order to obtain information on how to treat subsets of the target patient population or even the entire patient population at large.

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: February 1, 2021
• Primary Completion: July 23, 2025
• Study Completion: July 23, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)