Cannabis For Cancer-Related Symptoms

Investigators propose a study consisting of a series of N‐of‐1 trials comparing 3 different active cancer‐related symptom management treatments against a placebo treatment in terms of effectiveness and safety. Using formal statistical modeling, effectiveness will be assessed for single patients, for the entire patient population and for relevant subsets of the patient population defined by baseline patient characteristics. Safety will be assessed in a descriptive fashion for all patients who are part of the safety population. Subjects will be on treatment in the study for a minimum of 16 days with the opportunity to repeat the 16‐day cycle of cancer‐related symptom treatment with all four oil extracts up to 2 more times. The extracts will be supplied to subjects at the beginning of the study in four distinct 30‐ml bottles, randomly labelled as #1, #2, # 3 and # 4. The random labelling will be generated via a computer‐generated randomization code. The study will include at least 120 adult subjects (recruitment target 150 to allow for drop‐outs) residing in Canada who have symptoms from cancer and/or from cancer treatment but will exclude patients with active recreational use, cannabis use disorder, or high risk of diversion. Each treatment cycle will have a length of 16 days and will consist of 4 four‐day periods. The first 2 days of each 4‐day period will be a washout period where data will not be used for the analysis of effectiveness, to make sure there is no confusion with effects from the prior period. Subjects can use one and only one cannabis oil extract during each period to treat their cancer‐related symptom(s). Given a cannabis oil extract, the daily use of that extract by patients will involve the following: On each day within a specific treatment cycle, the patient will be asked to take a minimum of 3 drops of that extract per day (e.g., in the morning) and if any of the four major symptoms (nausea, pain, anxiety, and sleep disturbance) continue to trouble the patient as the day progresses, they will be instructed to take up to 3 drops every 4 hours for a maximum of 6 times a day (for a total of no more than 18 drops per day). All subjects will be instructed to use the following validated scales: Edmonton Symptom Assessment Scale (ESAS) and Patients' Global Impression of Change Scale (PGIC). The revised ESAS will be used modified to include sleep disturbance (previously validated), and added night sweats in replacement of the additional symptom option (ESAS‐r‐SN) because of reports of benefit of medical cannabis for this symptom and its relevance for sleep disturbance.This is in order to capture a complete picture of potential factors contributing to sleep disturbance. Additionally, subjects will be instructed to fill in a study medication use log which will record the timing and dose of each extract applications, any side effects associated with each application, as well as any rescue medication (if taken).