NCT07374939

Medical Cannabis for Nausea in Patients Receiving Moderately or Highly Emetogenic Chemotherapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 symptoms. Although cannabis is legal for medical use in many U.S. states and cancer is a qualifying condition, there is limited scientific evidence about how well cannabis works for chemotherapy-related nausea when used alongside modern anti-nausea medications. More research is needed to understand its benefits, risks, and how it may best be used. The purpose of this study is to collect early (pilot) data on whether medical cannabis can reduce nausea in adults receiving moderately or highly nausea-causing chemotherapy. The study will also examine whether cannabis affects vomiting, appetite, fatigue, sleep, pain, nerve pain, mood, and quality of life. In addition, blood samples will be collected to explore whether cannabis is associated with changes in inflammation related to cancer treatment. About 50 adults with cancer who are receiving chemotherapy will take part in this study at the University of Rochester Medical Center. Participants must be 21 years of age or older, experiencing significant nausea despite standard anti-nausea medications, and receiving chemotherapy that commonly causes nausea. People with certain medical or psychiatric conditions, recent cannabis use, or lung disease will not be eligible for safety reasons. Participants will be randomly assigned to one of two groups. One group will begin using medical cannabis during their first study chemotherapy cycle, while the other group will continue usual care for one cycle and then begin using medical cannabis during the next cycle. This delayed-start approach allows each participant to be compared to their own experience before and after cannabis use. All participants will continue to receive their prescribed anti-nausea medications throughout the study. Medical cannabis will be obtained through a state-licensed dispensary and used primarily during the four days surrounding each chemotherapy treatment, when nausea is most likely to occur. Cannabis will be used with a standardized vaporization device to help ensure consistent dosing. Participants will keep daily diaries to record nausea, vomiting, cannabis use, and any side effects. They will also complete questionnaires about symptoms, mood, and quality of life. Blood samples will be collected once per chemotherapy cycle during routine lab visits. Possible risks include side effects of cannabis such as dizziness, anxiety, sleepiness, or difficulty concentrating, as well as minor risks from blood draws such as bruising or lightheadedness. Participants will be given safety instructions, including avoiding driving after cannabis use. There may or may not be direct benefit to participants, but the information gained may help improve nausea management for future cancer patients. This study will provide important early evidence about the safety, feasibility, and potential benefits of medical cannabis for chemotherapy-related nausea and related symptoms, and will help guide larger future clinical trials.

Conditions

• Nausea and Vomiting Chemotherapy-Induced

Interventions

Type	Name	Description
DRUG	Medical 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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2026-01-29
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States