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 — DRUG
    Participant-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 Group
    Participants who independently choose to obtain and use Medical Cannabis during chemotherapy.
  • Arm: Standard Care Group
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rochester Medical CenterRochesterNew York14642
Luke J Peppone, PhD
5852757827
Liz Schifano, MSW
585-275-0690

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