Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06605430

A Randomized Phase II Trial of Medical Cannabis to Reduce Symptom Burden in Patients With Advanced Pancreatic and Colorectal Cancer (CanPan-C)

Led by HealthPartners Institute · Updated on 2025-07-29

64

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

H

HealthPartners Institute

Lead Sponsor

U

University of Minnesota

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the use of medical cannabis to reduce symptom burden in patients with advanced pancreatic and colorectal cancer. Many patients with these cancers experience difficult symptoms like nausea, pain, and wasting, which can lower quality of life and limit treatment tolerance. The study focuses on how medical cannabis might impact these symptoms and improve patient experiences during cancer care. Participants will be randomly assigned to two groups: one receiving medical cannabis immediately for 8 weeks at no charge, and the other starting cannabis after an 8-week delay. After the initial 8 weeks, those in the early group may continue cannabis for another 8 weeks but must cover the cost themselves, while the delayed group begins cannabis treatment during weeks 8 to 16. Medical cannabis dosing is guided by a pharmacist with close follow-up, and all participants must register with the Minnesota Medical Cannabis Program. Throughout the study, participants will complete weekly symptom reports and quality of life questionnaires at regular intervals up to 16 weeks. Researchers will assess recruitment feasibility, adherence to assigned groups, and symptom changes using patient-reported outcome tools. A close-out survey will be completed at the end of each participant's cannabis use period. The total study duration for each participant is up to 16 weeks, with careful monitoring of safety and symptom relief.

CONDITIONS

Brief Title

Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosed with advanced pancreatic or colorectal cancer confirmed by histology or cytology
  • No plans for curative surgery within the next 3 months
  • Experiencing symptoms such as nausea, vomiting, loss of appetite, wasting, or pain at least once in the past 14 days
  • Starting or have started standard chemotherapy (not immunotherapy) within the past 2 weeks
  • Resident of Minnesota
  • Willing to register with the Minnesota Medical Cannabis Program and follow its rules
  • Willing to complete baseline and ongoing patient-reported outcome surveys
Not Eligible

You will not qualify if you...

  • Regular use of THC-containing cannabis products (10 or more days in the past 30 days)
  • History of intolerance or hypersensitivity to cannabis
  • Diagnosis of Alzheimer's dementia, active epilepsy, or history of traumatic brain injury
  • Known active or untreated brain metastases
  • Currently receiving immunotherapy, chemo-immunotherapy combinations, or non-standard chemotherapy
  • Women who are pregnant, breastfeeding, or of childbearing potential not using birth control
  • Uncontrolled medical or psychiatric conditions that increase risk or interfere with study participation
  • Any condition that may jeopardize safety or protocol compliance as judged by the investigator

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for certification and registration with the Minnesota Medical Cannabis Program

Treatment

Duration - Up to 16 weeks

Participants receive medical cannabis either immediately for 8 weeks (Early Cannabis group) or after an 8-week delay (Delayed Cannabis group). The Early group may continue cannabis for an additional 8 weeks at their own cost, while the Delayed group starts cannabis during weeks 8 to 16.

Weekly visits for patient-reported outcomes during cannabis use; additional visits every 4 weeks for quality of life assessments

Trial Site Locations

Total: 1 location

1

HealthPartners Cancer Research Center

Saint Louis Park, Minnesota, United States, 55426

Actively Recruiting

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Research Team

A

Alissa Gavenda, RN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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