Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer

NCT06605430 | Recruiting Phase 2

• 1 other identifier: A24-183
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer Non-resectable; Pancreatic Cancer Metastatic; Colorectal Cancer Metastatic

Keywords

medical cannabis; patient-reported outcomes

Outcome Measures

Primary Outcomes (1)

• Assess feasibility for conducting a larger randomized trial by determining rate of recruitment, compliance with randomization group, and protocol adherence to this clinical trial.

  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.

  Early Cannabis - 8 weeks from cannabis initiation; Delayed Cannabis - 8 weeks from randomization

Study Arms (2)

Early Cannabis

EXPERIMENTAL

Drug: Medical Cannabis

Delayed Cannabis

EXPERIMENTAL

Drug: Medical Cannabis

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.

Delayed Cannabis; Early Cannabis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (aged 18 or more at enrollment)
• Histologically or cytologically proven pancreatic or colorectal cancer. Histologies may include listing of adenocarcinoma, poorly differentiated carcinoma, or other pathology terms that treating oncologist would consider managing per usual standard of care of pancreas and colorectal adenocarcinoma. Neuroendocrine tumors are excluded in both cancer types.
• Advanced stage (locally advanced or metastatic) pancreatic or colorectal cancer with no definitive plans for curative surgery in the next 3 months
• Self-report of experiencing nausea, vomiting, anorexia, cachexia (wasting), or pain at least once in the 14 days prior to randomization
• Plan to initiate or initiated within the past 2 weeks standard-of-care systemic chemotherapy (any regimen that does not include immunotherapy) at a participating institution with no prior systemic therapy in the prior 3 months (prior adjuvant or neoadjuvant chemotherapy is allowed as long as it was \>3 months prior to randomization)
• Must be a resident of Minnesota
• Must be willing to be registered in the Minnesota Medical Cannabis Program and follow all rules and requirements of the state program
• Must be willing to report baseline and required patient-reported outcomes

You may not qualify if:

• Self-reported regular use (using 10 or more days in the 30 days prior to randomization) of a THC containing cannabinoid product
• Patients with a history of intolerance or hypersensitivity to cannabis (i.e., cannabis hyperemesis)
• Patients with Alzheimer's dementia, active epilepsy, or history of traumatic brain injury
• Patients with known active or untreated brain metastases. A brain MRI is not required during the screening period.
• Patients initiating or receiving immunotherapy, a chemotherapy-immunotherapy combination, or non-standard cytotoxic chemotherapy (including patients enrolled/ enrolling in trials of investigational cancer-directed treatments)
• Women who are pregnant, breastfeeding or of childbearing potential without the use of birth control
• Uncontrolled acute or chronic medical conditions, psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for enrollment in this study
• Has any condition that in the opinion of the investigator might jeopardize the safety of the subject or interfere with protocol compliance

Sponsors & Collaborators

• HealthPartners Institute: lead
• University of Minnesota: collaborator

Study Sites (1)

HealthPartners Cancer Research Center

Saint Louis Park, Minnesota, 55426, United States

RECRUITING

MeSH Terms

Interventions

Medical Marijuana

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Central Study Contacts

Alissa Gavenda, RN

CONTACT

(952) 977-5555; cancercannabis@HealthPartners.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will recruit 64 total patients with advanced pancreatic cancer (n=32) and colorectal cancer (n=32). Participants in each cohort will be randomized 1:1 to early cannabis (EC) (n=16) versus delayed cannabis (DC) (n=16). The EC group will be provided with 8 weeks of medical cannabis at no charge. Following 8 weeks of cannabis, the EC group will be observed as per standard of care for the remaining 8 weeks. The DC 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.

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)