CAFCARS

About this trial

Last updated a year ago

Study ID

CAFCARS

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

Accepting

19+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 4 months ago

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).

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).