Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer

Part of paid clinical trials in Saint Louis Park, Minnesota.

Sponsor
HealthPartners Institute
Study ID
NCT06605430
Phase
PHASE2
Status
Recruiting
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Conditions

  • Colorectal Cancer Metastatic
  • Pancreatic Cancer Metastatic
  • Pancreatic Cancer Non-resectable

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Medical Cannabis — DRUG
    The Early Cannabis group will be provided with 8 weeks of medical cannabis at no charge. Following 8 weeks of cannabis, the Early Cannabis group will be observed as per standard of care for the remaining 8 weeks. The Delayed Cannabis group will receive usual care for the first 8 weeks, and then be provided up to 8 weeks of medical cannabis at no charge for the second 8 weeks. Prior to receiving cannabis, patients must first be certified by a provider for eligibility to receive medical cannabis before registering with the Minnesota Medical Cannabis Program. Collective experience with precise dosage CBMs supports a pharmacist-guided titration protocol with robust patient input and close patient follow up. The treating pharmacist in the Minnesota Medical Cannabis Program thoroughly instructs patients on dose titration at the initial visit.

Study Details

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.

Key Dates

Start date
Sep 16, 2024
Status verified
Jul 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Early Cannabis
  • Experimental: Delayed Cannabis

Primary Outcome Measure

Assess feasibility for conducting a larger randomized trial by determining rate of recruitment, compliance with randomization group, and protocol adherence to this clinical trial. [ Time Frame: Early Cannabis - 8 weeks from cannabis initiation; Delayed Cannabis - 8 weeks from randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
HealthPartners Cancer Research CenterSaint Louis ParkMinnesota55426
Alissa Gavenda, RN
[email protected]
952-977-5555

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By research site
HealthPartners Cancer Research Center· Saint Louis Park, MN

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