A randomized phase II trial of medical cannabis to reduce symptom burden in patients with newly diagnosed advanced colorectal cancer (CANCOL).

Abstract

TPS252 Background: Patients with advanced colorectal cancer often experience persistent and severe symptom burden. Medical cannabis shows promise in alleviating several cancer- and treatment-associated symptoms, but few randomized clinical trials assessing cannabis have been conducted, especially in the US, due to regulatory research barriers. With increasing access to cannabis through State programs, a key clinical question for patients and clinicians is whether early access to cannabis improves symptom burden. We seek to address this question in an investigator-initiated randomized, open-label phase II trial evaluating early vs delayed (waitlist control) access to a cannabis intervention for adults with colorectal cancer. Methods: Eligible participants are English-speaking adult (≥18 years) Minnesota-residents with newly diagnosed locally advanced or metastatic (AJCC stage III or IV) colorectal cancer, ≥1 self-reported symptom (e.g., pain, nausea, insomnia), and initiating systemic cytotoxic chemotherapy. Exclusion criteria include regular tetrahydrocannabinol (THC) use, cannabis hypersensitivity, neurological comorbidities, or untreated brain metastases. Thirty-two participants will be recruited at 2 sites (1 community, 1 academic) in Minnesota and randomized 1:1 to early (n=16) vs delayed (n=16) cannabis. The cannabis intervention includes cannabis certification, clinician- and pharmacist-guided education, a personalized dosing plan, and cannabis products provided for the study-period at no cost through the Minnesota Medical Cannabis Program. Medical cannabis therapy will be initiated at a standardized THC dose of 10 mg THC/day with oral products with guidance for increasing doses based on symptoms over the first 2 weeks. The early arm will receive the intervention from 0-8 weeks and the delayed arm from 9-16 weeks; the primary study period is 0-8 weeks when only the early arm receives the intervention. All standard-of-care oncology care can continue. Participants will complete e-surveys for symptom burden (PRO-CTCAE, weekly, assessing both efficacy such as pain, nausea, and insomnia, and potential harms such as difficulty concentrating and dry mouth), quality-of-life (PROMIS Global, every 4 weeks), and report cannabis and opioid use. Participants will complete an exit survey assessing their experiences, acceptability, and suggestions for future work. The primary outcome is feasibility (defined a priori as meeting each of: enrollment of eligible patients ≥20%, 8-week randomization compliance ≥60%, and weekly PRO completion ≥50%). Secondary outcomes include changes in symptom burden, quality-of-life, and opioid use, and descriptions of cannabis use patterns and participant experiences and acceptability. The trial opened to enrollment in September 2025. Clinical trial information: NCT06605430 .