A Health Canada-approved Whistler medical cannabis producer will donate the oil extracts to be taken by cancer patients in nine cities across Canada.
B.C. Cancer will lead a first-ever, national clinical trial that aims to answer whether cannabis plant extracts truly help with symptom relief.
Recruitment for the 48-day trial in 150 patients will begin soon after the expected Health Canada and ethics approval is obtained. Patients in Vancouver, Abbotsford, Prince George, Victoria, Calgary, Winnipeg, Ottawa, Kingston and Toronto will be enrolled in the trial investigating whether cannabis properties reduce cancer-related symptoms including pain, sleep disturbance, anxiety and nausea.
Funding of about $1 million for the randomized, double-blind, placebo-controlled study is coming from private donors to the BC Cancer Foundation; they’ve asked to remain anonymous. The cannabis oil-based products to be used will be donated by the Whistler Medical Marijuana Corp., one of the country’s first organic producers. The company has just been sold to Aurora Cannabis Inc. in a $175-million deal that has made headlines this week.
Dr. Pippa Hawley, a palliative care specialist and medical director of the provincial pain and symptom management program at B.C. Cancer, will lead the trial. She’s been providing authorizations for medical cannabis to patients for many years.
In an interview, Hawley said Canada’s legalization of marijuana paved the way for the study that should help answer whether patients’ anecdotal reports of benefits are justified by the evidence.
“My goal is to be able to provide a useful guide to patients and health care professionals,” said Hawley. “I want to be able to give them practical information about what could work.”
Prior to designing the trial methodology, Hawley and her collaborators circulated a survey to 3,000 patients who saw a cancer specialist at any one of the agency’s clinics across B.C. on a single day last summer. Patients were asked if they were using cannabis for symptom relief and if they had ever used cannabis. Eight hundred patients responded to the survey; a quarter said they were currently using cannabis products for cancer-related symptom control and another quarter said they had used it in the past, mostly for recreational purposes.
“That showed that cannabis use during treatment is widespread, for potential relief of symptoms related to treatment, or to cancer itself. This, in spite of the fact there is little or no scientific evidence into symptom and quality of life improvements,” she said, adding that evidence is urgently needed to advise patients on which products might help and which ones to avoid.
Since cannabis use is so prevalent and patients commonly extol its benefits, Her hypothesis is that at least one of the extracts will be more effective than placebo and that one will be a “high performer.”
The study will compare three cannabis extracts (high-THC/low CBD; low THC/high CBD; or equal amounts THC/CBD) against each other and to placebo. Each patient will be asked to titrate the doses (adjusting them in order to reduce his/her symptoms to the greatest degree while avoiding as many side effects as possible) according to the extent of their symptoms and then carefully rank (from zero to 10) their impressions of symptom changes.
Patients must meet strict criteria for entry into the trial. Those deemed too unstable will be excluded and that means that patients undergoing chemotherapy or radiation can’t be participants because their health and symptoms could be too changeable from one day to the next. Patients taking oral chemotherapy medications or hormone withdrawal therapy, for example, would qualify.
Hawley said even though that means many patients will be excluded, she still believes it would be “reasonable to extrapolate” that if cannabis works in stable patients it might also work in others undergoing more intense treatment.
“While the results of this study will allow us to identify which symptoms respond to which types of cannabinoids, additional research will be needed to understand with more precision the most effective dosage required for each symptom, depending on their severity,” she said.
Hawley expects recruitment will begin by the middle of the year. Data collection should be completed by the end of the year and then the study results could be published in a medical journal by June, 2020. Patients who are interested in the trial can speak with their oncologists to ensure they are considered for inclusion.
HOW THE TRIAL WILL WORK
The B.C. Cancer trial aims to find out if one of three cannabis extract combinations (High THC-Low CBD, Low THC-High CBD, or equal amounts of THC and CBD) is more effective at treating cancer-related symptoms than placebo. Each patient will be given a set of four identical looking vials numbered one through four:
- three containing three different cannabis oil combinations;
- one with placebo oil.
The order in which the patient takes each vial will be randomly allocated.
- Patients will take the oils from each vial (in order of sequence) for four days for a total cycle time of 16 days (for the set of four vials);
- Each patient will then repeat the cycle two more times for a total study duration of 48 days;
- Patients will be instructed to start with three drops on the morning of treatment days with an additional 1-3 drops every four hours as necessary up to a total of 18 drops in a 24-hour period.
- On the second and third cycles, patients will start that day with the optimal dose they determined for that oil on the previous cycle, thereby providing a total of 12 days of dose-finding for each extract over the course of the study.
On each treatment day, patients will record in a journal the number of drops used and reasons for taking the extract. The effect the extract had on symptoms will be ranked daily using the Edmonton System Assessment Scale (ESAS-R) and the Patient Global Impression of Change Scale (PGIC).