Pancreatic Cancer Non-resectablePhase 2CanPan-CNCT06605430
Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer
A Phase 2 study testing Medical Cannabis in people with Pancreatic Cancer Non-resectable and Pancreatic Cancer Metastatic, run by HealthPartners Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer Non-resectable, Pancreatic Cancer Metastatic, Colorectal Cancer Metastatic
- What is being tested?
- Medical Cannabis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to Jan 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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)
- Must be a resident of Minnesota
- Must be willing to be registered in the Minnesota Medical Cannabis Program and follow all rules and requirements of the state program
- Must be willing to report baseline and required patient-reported outcomes
Who cannot join
- 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.
- 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)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
HealthPartners Cancer Research Center
Saint Louis Park, Minnesota, 55426
Alissa Gavenda, RN, 952-977-5555, cancercannabis@HealthPartners.com
About this study
Official title: A Randomized Phase II Trial of Medical Cannabis to Reduce Symptom Burden in Patients With Advanced Pancreatic and Colorectal Cancer (CanPan-C)
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.
Read the detailed description
Participants will be randomized 1:1 to receive "early'' or "delayed'' medical cannabis. The early group will have access to medical cannabis immediately at no charge, while the delayed group will agree not to use cannabis of any type during the first 8 weeks. The primary study period for assessing the primary aim is 0 - 8 weeks. Participants in the early arm will have an option to receive cannabis at no charge for another 8 weeks (total 16 weeks), but will be responsible for the cost of the cannabis in this second 8 week period. Participants in the delayed arm will use cannabis from weeks 8 to 16. This secondary study period (8-16 weeks) will be used to assess the proportion of participants in the early arm who choose to continue cannabis, persistence of symptom relief with cannabis, and ongoing safety signals. Patients in the delayed group will complete patient-reported outcomes using NCI PRO-CTCAE (PRO) (weekly) and PROMIS Global (QOL) (every 4 weeks) through 16 weeks. Patients in the early group will complete PRO (weekly) and QOL (every 4 weeks) through week 8, then PRO/QOL every 4 weeks until week 16. All patients will complete a close out survey at the end of their cannabis administration period.
- Conditions
- Pancreatic Cancer Non-resectable, Pancreatic Cancer Metastatic, Colorectal Cancer Metastatic
- Being tested
- Medical Cannabis
- Keywords
- medical cannabis, patient-reported outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical CannabisDrug
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Early Cannabis | Experimental | Not described Receives: Drug: Medical Cannabis |
| Delayed Cannabis | Experimental | Not described Receives: Drug: Medical Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Early Cannabis - 8 weeks from cannabis initiation; Delayed Cannabis - 8 weeks from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start16 Sep 2024
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer Non-resectableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- We will recruit 64 total patients with advanced pancreatic cancer (n=32) and colorectal cancer (n=32). Participants in each cohort will be randomized 1:1 to early cannabis (EC) (n=16) versus delayed cannabis (DC) (n=16). The EC group will be provided with 8 weeks of medical cannabis at no charge. Following 8 weeks of cannabis, the EC group will be observed as per standard of care for the remaining 8 weeks. The DC 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.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605430
- Sponsor's protocol ID
- A24-183
- Acronym
- CanPan-C
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No