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
Qualifiers
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
Treatments tested in this trial
- Medical Cannabis
Treatment groups
64 Participants
are divided into 2 treatment groupsSponsors and collaborators
HealthPartners Institute
Lead sponsor
University of Minnesota
Collaborator
Source ClinicalTrials.gov