Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHealthPartners Institute
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Medical Cannabis
DrugThe 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.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Early CannabisExperimental treatment 1 intervention
Group B: Delayed CannabisExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Early Cannabis - 8 weeks from cannabis initiation; Delayed Cannabis - 8 weeks from randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
HealthPartners Institute
Lead sponsor
University of Minnesota
Collaborator
Source ClinicalTrials.gov