In this innovative approach seeking effective therapeutic strategies, the investigators are proposing to test the effectiveness of medical cannabis oil as an adjunct to palliative Radiation Therapy (RT) and Best Supportive Care to alleviate cancer pain that was only partially relieved with conventional medications. Furthermore, the investigators will assess the effect of medical cannabis oil on health-related quality of life and symptoms that are frequently associated with metastatic cancers including fatigue, anxiety, depression, insomnia and decreased appetite. The safety profile of medical cannabis oil with respect to prolonged use of more than two weeks of administration, concomitant medication use and palliative RT will also be examined.
This is a 6-week randomized, double-blind, placebo-controlled, parallel group design trial followed by an open-label extension phase of 12 weeks, to evaluate tolerability of medical cannabis oil to reduce chronic pain intensity. Consecutive adult patients between the ages of 18 and 75, male and female, with cancer pain, with an average weekly pain intensity score greater than 4 on the 11 points Numerical Rate Scale (NRS), will be prospectively recruited and invited to participate in this trial. Informed consent will be obtained by a Research Assistant. After baseline documentation with standardized scales, patients will be randomized to one of two parallel groups: * Cannabis group: Delta-9 Tetrahydrocannabidiol (THC) /Cannabidiol (CBD) ratio 1:1 capsule * Placebo group: Placebo capsule * All patients will receive palliative RT to the symptomatic site. Patients will have a dose titration phase during the first week. The dose escalation will allow patients to adapt to the potential adverse effects (AEs) of the medical cannabis. Follow-up visits either in person or by phone will be at 1 week, 3 weeks and 6 weeks of treatment. At the end of the first phase of the study, patients who wish to participate in the open-label extension phase will have the option to continue in the same treatment regimen. For the placebo group, patients will have the option to receive the active treatment during the 12-week open-label phase if the study physician feels it may potentially provide benefits. Similarly, the dose will be titrated up in the placebo group who wants to receive the active drug in the extension program. The open-label phase is 12 weeks long. For this open-label extension phase the follow-up visits will be done after 4 weeks and 12 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Group assigned to active PPP005 in the randomized placebo-controlled trial
Palliative RadioTherapy to the symptomatic site
Sante Cannabis
Montreal, Quebec, Canada
Cancer pain intensity assessed by Pain Intensity (PI) measurement a numerical rating scale
Pain Intensity (PI) measurement a Numerical Rating Scale (zero= no pain and 10= pain as bad as it can be). A reduction of PI ≥ 33% will be considered as a clinically important level of pain relief
Time frame: Change (a reduction of 30% in pain intensity) in pain intensity after medical cannabis oil administration compared to placebo at 6 weeks compared to baseline
Cancer pain quality using the Brief Pain Inventory-SF (BPI-SF)
The BPI-SF consists of nine questions; eight have a single response, and Question 9 is subdivided into seven parts. The Total BPI for Question 9 is the unweighted sum of the seven assessments and represents the effect of pain
Time frame: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment
Impact of medical cannabis oil combined with radiation treatment on HRQoL as measured by the EQ-5D-5L
Time frame: at baseline, 1-week, 3-week, and 6-week follow-up
Functional status assessed by the Functional Assessment of Cancer Therapy for Prostate patients (FACT-P).
Time frame: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment
Fatigue burden assessed by the Brief Fatigue Inventory (BFI).
Time frame: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment
Cognitive status assessed by the Mini-Cog
Time frame: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment
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