A Randomized Phase II Trial of Medical Cannabis to Reduce Symptom Burden in Patients with Advanced Pancreatic Cancer (CanPan)
Principal Investigator: Dylan Zylla, MD
Study Sponsor: HealthPartners Institute
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase II
Purpose of study: This is a symptom management study, and many patients with Pancreatic Ductal Adenocarcinoma (PDAC) 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. The study is looking to determine whether adding cannabis to patient’s treatment plan can improve their symptom burden.
Inclusion Criteria:
– Are at least 18 years old
– Have been diagnosed with locally advanced or metastatic pancreatic cancer and are planning to start systemic treatment for the first time in the metastatic setting, or have started within the last two weeks
– Are experiencing nausea, vomiting, anorexia (loss of appetite), cachexia (wasting), or pain at least once in the 14 days prior to starting the study
– Are eligible and willing to register in the Minnesota Medical Cannabis Program (MMCP)
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, 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 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
Study Contact:
Alissa Gavenda, RN OCN
(952) 993-6705
alissa.gavenda@parknicollet.com
