Pilot Randomized Trial of Medical Cannabis to Reduce Symptom Burden in Patients With Newly Diagnosed Advanced...

Patients with pancreatic adenocarcinoma frequently experience severe symptoms. Medical cannabis has shown promise for symptom management, yet high-quality data are lacking because of regulatory barriers in conducting cannabis research. Partnering with state cannabis programs may represent a novel pathway to conduct cannabis trials.

We conducted a pilot randomized waitlist-controlled trial of medical cannabis for 32 patients with newly diagnosed locally advanced/metastatic pancreatic adenocarcinoma with ≥1 symptoms in Minnesota. Patients were randomly assigned 1:1 to early (0-8 weeks) or delayed (9-16 weeks) cannabis intervention (certification, education, provision of cannabis products) through the Minnesota Medical Cannabis Program. The primary study period was 0-8 weeks when only the early arm received the intervention. The primary outcome was feasibility. Secondary outcomes included acceptability, and changes in symptom burden and quality of life examined in exploratory efficacy analyses.

We enrolled 34 patients, 32 of whom began the study (median age 71 years, 53% women). Patients reported substantial moderate-to-severe baseline symptom burden: insomnia (85%), pain (77%), and appetite loss (69%). The study met prespecified feasibility benchmarks (74% enrollment (goal ≥20%), 81% compliance with arm allocation (goal ≥60%), and 75% patient-reported outcome completion rate [goal ≥50%]). All early arm participants recommended the intervention to others. The median daily tetrahydrocannabinol use was 7.3 mg at 8 weeks. At 8 weeks, early arm patients experienced numerically higher rates of improvement in pain (44% v 20%, P = .35), appetite (56% v 30%, P = .37), and insomnia (67% v 30%, P = .18), and lower rates of worsening cannabis-related harms (eg, dry mouth [11% v 20%, P = .99]).

We demonstrate a model collaboration between investigators and a state cannabis program to overcome regulatory barriers to conducting interventional cannabis research. The encouraging preliminary efficacy and safety of cannabis in managing symptoms supports further exploration.