Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer
A Randomized Phase II Trial of Medical Cannabis to Reduce Symptom Burden in Patients With Advanced Pancreatic and Colorectal Cancer (CanPan-C)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "All patients will complete a close out survey at the end of their cannabis administration period."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether medical cannabis can help ease symptoms in adults with advanced pancreatic or colorectal cancer. It is for Minnesota residents who are starting or have just started standard chemotherapy.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Have pancreatic or colorectal cancer confirmed by tissue or cell tests. Neuroendocrine tumors, which start in hormone-making cells, are not allowed.
- Have cancer that has spread nearby or to other parts of the body, with no firm plan for surgery to cure it in the next 3 months.
- Have had nausea, vomiting, loss of appetite, body wasting (weight and muscle loss), or pain at least once in the 14 days before study group assignment.
- Plan to start standard chemotherapy at a study site, or have started within the past 2 weeks. It must not include immunotherapy (treatment that uses the immune system). Apart from this new treatment, you must have had no cancer treatment that travels through the body in the prior 3 months.
- Live in Minnesota.
- Be willing to join the Minnesota Medical Cannabis Program and follow its rules.
- Be willing to report your symptoms and health before the study treatment and at required times.
Who can't join
- Used a cannabis product with THC on 10 or more days in the 30 days before study group assignment.
- Have had an allergy or trouble tolerating cannabis, such as severe vomiting caused by cannabis.
- Have Alzheimer's dementia, active epilepsy (a seizure disorder), or a past brain injury caused by trauma.
- Have known active or untreated cancer that has spread to the brain.
- Are starting or receiving immunotherapy, chemotherapy with immunotherapy, or nonstandard cell-killing chemotherapy. This includes joining a trial of an experimental cancer treatment.
- Are pregnant, breastfeeding, or able to become pregnant but not using birth control.
- Have an uncontrolled medical or mental health condition, or an abnormal lab result, that the study doctor thinks could make participation unsafe or affect the results.
- Have any other condition that the study doctor thinks could make participation unsafe or keep you from following study rules.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
MN
- HealthPartners Cancer Research Center · Saint Louis Park, MN 55426Alissa Gavenda, RN · Study contact · 952-977-5555 · cancercannabis@HealthPartners.comMore trials in Saint Louis Park