The first- national clinical trial of medical cannabis oil extracts for multiple cancer-related symptoms has re-opened and is recruiting patients and cancer survivors who continue to experience cancer-related symptoms.
The study will evaluate three cannabis oils, using extracts already publicly available, on four cancer-related symptoms: nausea, pain, anxiety, and insomnia. A fourth oil, a placebo, will also be included in the study. Because cancer-related symptoms are not experienced in isolation, it’s important to study the impact of cannabis-based medicines on the overall set of symptoms; not just one-by-one. For example, pain may be worsened by insomnia and anxiety, or anxiety may be intensified by nausea and pain.
“Many patients are taking cannabis-based products, in different forms and from multiple sources, some less than ideal,” says lead researcher Dr. Pippa Hawley, medical director, Provincial Pain & Symptom Management and Palliative Care Program at BC Cancer. “We urgently need good trial data to inform this subject, so we can maximize benefits and minimize harms to patients.”
In a survey of nearly one thousand BC Cancer patients, a quarter indicated they were using cannabis products for medicinal purposes, commonly as oils, and often from an unlicensed or unregulated source such as a storefront dispensary or from a friend. Patients indicated they were taking cannabis products with little to no guidance or monitoring by their doctor.
Although cannabis products are legally available, health care professionals may not be comfortable providing clinical guidance on the use of cannabis products due to a lack of clear scientific evidence. The 48-day study, which will consist of three 16-day cycles, is currently recruiting at BC Cancer centres in Vancouver and Victoria, available remotely across the province, and open at select cancer centres across Canada. The results from this clinical study will provide information to support clinicians to make informed decisions about which products patients could take, or to avoid, and which doses might provide therapeutic effects for people living with cancer.
“Cannabis products have shown potential for benefit in many cancer-related symptoms,” says Dr. Hawley. “However, these symptoms are subjective and can impact each other. That’s why it is important to study the impact of cannabis-based medicines on symptoms cancer patients experience as a whole, as well as trying to tease out effects on individual symptoms.”
The cannabis oils used in this study will be taken orally under the tongue and is not intended as a cancer treatment. This study will provide information about the dosing and safety of the cannabis product that is being studied. The study is double-blind, meaning that neither the participants nor their doctors will know which bottles contain which products.
“I am proud of the patient-oriented methodology that we’re using in this research,” says Dr. Hawley. “Patients who participate in the study will self-report multiple symptoms, which reflects the way patients anecdotally report on their experience with cannabis. We are also the first big trial using extracts already available for patients, which is a significant achievement.”
BC Cancer is sponsoring this study and the BC Cancer Research Ethics Board (REB) reference number is H18-03724.