NCT06605430 Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer
| NCT ID | NCT06605430 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | HealthPartners Institute |
| Condition | Pancreatic Cancer Non-resectable |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 64 participants in total. It began in 2024-09-16 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria 1. Adults (aged 18 or more at enrollment) 2. 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. 3. Advanced stage (locally advanced or metastatic) pancreatic or colorectal cancer with no definitive plans for curative surgery in the next 3 months 4. Self-report of experiencing nausea, vomiting, anorexia, cachexia (wasting), or pain at least once in the 14 days prior to randomization 5. 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) 6. Must be a resident of Minnesota 7. Must be willing to be registered in the Minnesota Medical Cannabis Program and follow all rules and requirements of the state program 8. Must be willing to report baseline and required patient-reported outcomes Exclusion Criteria 1. Self-reported regular use (using 10 or more days in the 30 days prior to randomization) of a THC containing cannabinoid product 2. Patients with a history of intolerance or hypersensitivity to cannabis (i.e., cannabis hyperemesis) 3. Patients with Alzheimer's dementia, active epilepsy, or history of traumatic brain injury 4. Patients with known active or untreated brain metastases. A brain MRI is not required during the screening period. 5. 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) 6. Women who are pregnant, breastfeeding or of childbearing potential without the use of birth control 7. 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 8. Has any condition that in the opinion of the investigator might jeopardize the safety of the subject or interfere with protocol compliance
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06605430 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer Non-resectable. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06605430 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06605430 currently recruiting?
Yes, NCT06605430 is actively recruiting participants. Contact the research team at cancercannabis@HealthPartners.com for enrollment information.
Where is the NCT06605430 trial being conducted?
This trial is being conducted at Saint Louis Park, United States.
Who is sponsoring the NCT06605430 clinical trial?
NCT06605430 is sponsored by HealthPartners Institute. The trial plans to enroll 64 participants.
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