Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer

Phase 2

Recruiting

• Conditions: Pancreatic Cancer Non-resectable; Colorectal Cancer Metastatic; Pancreatic Cancer Metastatic
• Interventions: Drug: Medical Cannabis

• Registration Number: NCT06605430
• Lead Sponsor: HealthPartners Institute

Brief Summary

Many patients with advanced pancreatic cancer and colorectal cancer experience burdensome and difficult-to-treat symptoms. The impact of multiple symptoms (called "symptom burden") can negatively affect a patient's quality of life, decrease their ability to tolerate cancer treatments, and lead to worse survival. Current approaches to manage these cancer-associated symptoms often work poorly, with most patients reporting a moderate to severe symptom burden. Therefore, there is an urgent need for treatments that improve these symptoms in patients with advanced pancreatic and colorectal cancer, and data suggests that medical cannabis can help. In this research study, we are examining the usefulness of using medical cannabis in patients with advanced pancreatic cancer and colorectal cancer to further study how cannabis can impact their symptom burden.

Detailed Description

Participants will be randomized 1:1 to receive "early'' or "delayed'' medical cannabis. The early group will have access to medical cannabis immediately at no charge, while the delayed group will agree not to use cannabis of any type during the first 8 weeks. The primary study period for assessing the primary aim is 0 - 8 weeks. Participants in the early arm will have an option to receive cannabis at no charge for another 8 weeks (total 16 weeks), but will be responsible for the cost of the cannabis in this second 8 week period. Participants in the delayed arm will use cannabis from weeks 8 to 16. This secondary study period (8-16 weeks) will be used to assess the proportion of participants in the early arm who choose to continue cannabis, persistence of symptom relief with cannabis, and ongoing safety signals. Patients in the delayed group will complete patient-reported outcomes using NCI PRO-CTCAE (PRO) (weekly) and PROMIS Global (QOL) (every 4 weeks) through 16 weeks. Patients in the early group will complete PRO (weekly) and QOL (every 4 weeks) through week 8, then PRO/QOL every 4 weeks until week 16. All patients will complete a close out survey at the end of their cannabis administration period.

Study Timeline

• Study Start: 2024-09-16
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-09-18
• Study First Posted: 2024-09-20
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-29
• Primary Completion: 2026-09
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Early Cannabis	Medical Cannabis	-
Delayed Cannabis	Medical Cannabis	-

Primary Outcome Measures

Name	Time	Method
Assess feasibility for conducting a larger randomized trial by determining rate of recruitment, compliance with randomization group, and protocol adherence to this clinical trial.	Early Cannabis - 8 weeks from cannabis initiation; Delayed Cannabis - 8 weeks from randomization	Achieve successful completion of feasibility trial by demonstrating the following: a) 64 patients enrolled (enrollment goal in each cohort is to enroll 32 patients within an 18 month period), b) at least 60% of eligible patients who are offered participation enroll in the trial, c) at least 20% of patient screened for eligibility enroll in the trial, d) at least 60% of patients comply with randomization group through week 8, and e) patients in both early and delayed group complete at least 50% of weekly PROs through week 8.

Trial Locations

Locations (1)

HealthPartners Cancer Research Center; 🇺🇸 Saint Louis Park, Minnesota, United States