Medical Cannabis Observational Study for Antiemetic Intervention in Chemotherapy
Part of paid clinical trials in Rochester, New York.
- Sponsor
- University of Rochester
- Study ID
- NCT07374939
- Status
- Not Yet Recruiting
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Conditions
- Nausea and Vomiting Chemotherapy-Induced
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Medical Cannabis — DRUGParticipant-directed medical cannabis use
Study Details
The goal of this observational study is to evaluate the associations between patient-directed medical cannabis use and chemotherapy-induced nausea and vomiting (CINV), as well as other treatment-related symptoms, among patients receiving chemotherapy that is known to cause nausea. The main questions it aims to answer are: * Is patient-directed medical cannabis use associated with reduced nausea severity during chemotherapy treatment? * Is-patient directed medical cannabis use associated with improved CINV control? * Is patient directed medical cannabis use associated with improved appetite during chemotherapy treatment? * Is patient-medical cannabis use associated with reduced treatment-related side effects, such as fatigue, sleep disturbances, general pain, and peripheral neuropathic pain? Researchers will compare participants who report using medical cannabis with participants who do not report using medical cannabis to determine whether differences exist in nausea, CINV outcomes, and other treatment-related symptoms. Participants will be followed over the course of 3 chemotherapy cycles, and asked to complete questionnaires, nausea diaries, and partake in a blood sample collection. Study participation can last from 6 - 12 weeks, depending on their prescribed chemotherapy cycle frequency.
Key Dates
- Start date
- Sep 1, 2026
- Status verified
- Jun 2026
- Primary completion
- Mar 1, 2028
- Completion
- Mar 1, 2028
Study Design
- Enrollment
- 50 participants (estimated)
Arms
- Arm: Cannabis Use GroupParticipants who independently choose to obtain and use Medical Cannabis during chemotherapy.
- Arm: Standard Care GroupParticipants who choose not to use cannabis and continue with antiemetic therapy as prescribed by their oncology care team.
Primary Outcome Measure
Average and Maximum Nausea Severity as Measured by the Nausea and Vomiting Diary [ Time Frame: Days 1-4 following chemotherapy administration during up to 3 on-study chemotherapy cycles (Day 1 defined as the day of chemotherapy administration; each chemotherapy cycle is 14-28 days, depending on regimen) ]
Central Contacts
- Luke Peppone, PhD585-275-7827
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 |