Medical Cannabis in Patients With Advanced Pancreatic Cancer

Trial Title: Medical Cannabis in Patients With Advanced Pancreatic Cancer

NCT ID: NCT06605430

Condition: Pancreatic Ductal Adenocarcinoma (PDAC)

Conditions: Official terms:
Adenocarcinoma

Conditions: Keywords:
metastatic pancreatic ductal adenocarcinoma
medical cannabis
patient-reported outcomes

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Crossover Assignment

Intervention model description: Participants 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.

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Medical Cannabis
Description: 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.
Arm group label: Delayed Cannabis
Arm group label: Early Cannabis

Summary: 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. Current approaches to manage PDAC-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 PDAC, and data suggests that medical cannabis can help. In this research study, we are examining the usefulness of using medical cannabis in patients with pancreatic cancer to further study how cannabis can impact their symptom burden.

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 then have an option to receive cannabis at no charge for another 8 weeks (total 16 weeks). Participants in the delayed arm will receive cannabis from weeks 8 to 16 at no charge. 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Adults (aged 18 or more at enrollment) - Histologically or cytologically proven PDAC - Advanced stage (locally advanced or metastatic) PDAC with no definitive plans for curative surgery in the next 4 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) 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 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: HealthPartners Cancer Research Center

Address:
City: Saint Louis Park
Zip: 55426
Country: United States

Status: Recruiting

Contact:
Last name: Alissa Gavenda, RN

Phone: 952-977-5555
Email: cancercannabis@HealthPartners.com

Start date: September 16, 2024

Completion date: December 2026

Lead sponsor:
Agency: HealthPartners Institute
Agency class: Other

Collaborator:
Agency: University of Minnesota
Agency class: Other

Source: HealthPartners Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06605430