Status:
RECRUITING
Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer
Lead Sponsor:
HealthPartners Institute
Collaborating Sponsors:
University of Minnesota
Conditions:
Pancreatic Cancer Non-resectable
Pancreatic Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 affe...
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 agre...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06605430
Start Date
September 16 2024
End Date
December 1 2026
Last Update
July 29 2025
Active Locations (1)
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1
HealthPartners Cancer Research Center
Saint Louis Park, Minnesota, United States, 55426