A Randomized Trial Of Medical Cannabis (Mc) In Patients With Advanced Cancer (Ac) To Assess Impact On Opioid Use And Cancer-Related Symptoms.

109 Background: Higher pain and greater long-term opioid requirements have been associated with shorter survival and decreased quality of life (QOL) in patients with AC. Routine use of MC is limited by a lack of rigorous scientific data and concerns about side effects, legal ramifications, and cost. Methods: 30 patients with stage IV cancer requiring opioids were randomized 1:1 to early cannabis (EC, n=15) vs. delayed cannabis (DC, n=15). The EC group was provided with 3 months (3M) of MC at no charge, while the DC group received standard oncology care without MC for the first 3M. Patients met with licensed pharmacists at one of two MC manufacturers to determine optimal MC dosing, formulation, and route. Patients completed monthly pain logs, opioid/MC logs, and validated Patient-Reported Symptom Monitoring surveys. Results: A higher proportion of EC patients achieved a reduction in opioid use and improved pain control. On average over a 3M window, EC patients did not require opioid dose escalation, had lower mean pain, and had similar QOL compared to DC patients. Estimated mean daily THC and CBD dose at 3M was 76 mg (range 5-186 mg) and 36 mg (range <1-516 mg), respectively. Mean perceived benefit of MC was 5.1 and mean perceived negative impact was 2.7 (1 = no benefit/negative effects, 7 = a great deal of benefit/negative effects). 33% of patients died during the anticipated 6-month study period and patient compliance with study logs limited analysis. Conclusions: Randomized studies of MC in the oncology setting are feasible, but rigorous data collection is challenging. The addition of MC to standard oncology care in patients with AC was well-tolerated and may lead to improved pain control and lower opioid requirements. [Table: see text]