Medical Cannabis for Nausea in Patients Receiving Moderately or Highly Emetogenic Chemotherapy
University of Rochester
Summary
Many people receiving chemotherapy experience nausea despite standard anti-nausea medications. Medical cannabis is commonly used to help manage nausea, but there is limited scientific evidence about its effectiveness when used alongside modern chemotherapy treatments. This study will evaluate whether medical cannabis can reduce nausea in adults receiving moderately or highly nausea-causing chemotherapy. Participants will be randomly assigned to start medical cannabis either immediately or after one chemotherapy cycle, allowing comparison of symptoms with and without cannabis use. All participants will continue their usual anti-nausea medications. The study will also examine effects on vomiting, appetite, pain, fatigue, sleep, mood, quality of life, and inflammation. Results from this pilot study will help determine the safety, feasibility, and potential benefits of medical cannabis for chemotherapy-related nausea and guide future larger clinical trials.
Description
Many people receiving chemotherapy experience nausea, even when they are given standard anti-nausea medications. Vomiting is now often well controlled, but nausea, especially nausea that occurs one or more days after chemotherapy, remains a major problem. Nausea can interfere with daily activities, reduce appetite, worsen quality of life, and sometimes lead to dehydration or delays in cancer treatment. New approaches are needed to better manage chemotherapy-related nausea. Medical cannabis is commonly used by patients to help with nausea, appetite, sleep, pain, and other treatment-related sym…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Have a diagnosis of cancer with no previous chemotherapy treatments (aside from current treatment) * Be scheduled to receive treatment with a chemotherapeutic agent that is classified by the National Comprehensive Cancer Network (NCCN) as having a high emetogenic potential (\>90% incidence) or moderate emetogenic potential (30-90% incidence). * Must be scheduled for a minimum of 3 additional chemotherapy cycles at the time of enrollment. * Chemotherapy agents may be given intravenously or orally. * Chemotherapy cycles must be at least two weeks apart. * For the purposes…
Interventions
- DrugMedical Cannabis
Medical cannabis will be used as an adjunct to standard guideline-recommended antiemetic therapy for chemotherapy-related nausea. Participants will obtain state-certified medical cannabis products through a New York State-licensed dispensary and self-administer cannabis via vaporization using a standardized device. Dose limits and timing of use will be guided by the study protocol to promote consistency while allowing individualized use. Medical cannabis will be used during the acute and delayed nausea period, defined as Days 1 through 4 following chemotherapy administration. Participants randomized to the Immediate Use arm will initiate cannabis use during their first on-study chemotherapy cycle, whereas participants randomized to the Delayed Use arm will initiate cannabis use after completion of the first cycle. Cannabis use patterns, nausea and vomiting symptoms, adverse effects, and patient-reported outcomes will be recorded using participant-completed diaries and questionnaires.
Location
- University of Rochester Medical CenterRochester, New York