Medical Cannabis for Nausea and Vomiting
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether medical cannabis can reduce nausea in adults undergoing chemotherapy that often causes these symptoms. It compares starting cannabis immediately with starting it after one chemotherapy cycle, while continuing standard anti-nausea medications. The study also examines effects on vomiting, appetite, pain, and other quality-of-life factors. Candidates may qualify if they have cancer, have not yet started chemotherapy, and are scheduled for at least three more cycles of a type known to cause nausea. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
No, you can continue taking your usual anti-nausea medications during the trial.
Is there any evidence suggesting that medical cannabis is likely to be safe for humans?
Studies have shown that cannabinoids, compounds found in cannabis, can safely manage nausea and vomiting caused by chemotherapy. Some patients have combined medical cannabis with their regular anti-nausea medications and found it helpful. The FDA has approved cannabinoid treatments like Dronabinol and Nabilone for this purpose, indicating they are generally well-tolerated.
While medical cannabis can alleviate nausea, some people might experience side effects. Not everyone reacts the same way. This ongoing research will explore the safety and effectiveness of medical cannabis when used with chemotherapy. The study findings will guide future trials and treatment options.12345Why are researchers excited about this trial's treatment?
Most treatments for chemotherapy-induced nausea and vomiting rely on antiemetic drugs that target neurotransmitters like serotonin and dopamine. Unlike these standard medications, medical cannabis offers a different approach by activating the endocannabinoid system, which plays a role in regulating nausea and vomiting. Researchers are excited about this treatment because it uses vaporized cannabis, allowing for rapid relief of symptoms with precise dosing. Additionally, medical cannabis could potentially reduce the need for multiple antiemetic drugs, simplifying patient care and minimizing side effects.
What evidence suggests that medical cannabis might be an effective treatment for nausea?
This trial will compare the effects of immediate versus delayed use of medical cannabis for chemotherapy-related nausea and vomiting. Research has shown that a mix of THC and CBD, two compounds from cannabis, can help reduce nausea and vomiting caused by chemotherapy. Studies indicate that combining this mix with standard anti-nausea drugs manages these symptoms better than the drugs alone. However, some patients might experience additional side effects when using medical cannabis. While the results are promising, further research is needed to fully understand the benefits and risks.12346
Are You a Good Fit for This Trial?
Adults scheduled for at least 3 more chemotherapy cycles, with treatments spaced two weeks apart, can join this trial. They must be receiving chemo that's known to cause moderate to severe nausea and have not had previous chemo (except current treatment).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive medical cannabis during chemotherapy cycles to evaluate its effect on nausea and other symptoms
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Medical Cannabis
Trial Overview
The study tests if medical cannabis reduces nausea in patients undergoing certain chemotherapies. Participants will either start cannabis immediately or after one cycle, while continuing standard anti-nausea meds, allowing comparison of its effects.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to the Immediate Use arm will receive New York State medical cannabis certification and initiate medical cannabis use during their first on-study chemotherapy cycle, in addition to standard guideline-recommended antiemetic therapy. Participants will use medical cannabis primarily during the four days surrounding chemotherapy administration, corresponding to the acute and delayed nausea period. Cannabis will be administered by vaporization using a standardized device, dose limits, and schedule. Participants will complete daily nausea and vomiting diaries, cannabis use logs, and symptom questionnaires, and will provide blood samples once per chemotherapy cycle. Outcomes in this arm will be compared to the delayed-use arm to evaluate the preliminary efficacy, safety, and feasibility of medical cannabis for chemotherapy-related nausea.
Participants randomized to the Delayed Use arm will receive standard guideline-recommended antiemetic therapy alone during their first on-study chemotherapy cycle and will not use medical cannabis during this initial evaluation period. This cycle will serve as the comparison condition for nausea outcomes. After completion of the first cycle assessments, participants will receive New York State medical cannabis certification and will initiate medical cannabis use during the subsequent chemotherapy cycle. Cannabis will be administered by vaporization using a standardized device, dose limits, and schedule, primarily during the four days surrounding chemotherapy administration. Participants will complete daily nausea and vomiting diaries, cannabis use logs, symptom questionnaires, and provide blood samples once per chemotherapy cycle to evaluate changes after cannabis initiation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Rochester
Lead Sponsor
Citations
Cannabinoids in Treating Chemotherapy-Induced Nausea ...
One study found no improvement in HRQoL when THC was used to treat chemotherapy-induced nausea and vomiting in 32 patients with primary brain ...
Final Results of a Randomized, Placebo-Controlled, Phase ...
THC:CBD is an effective adjunct for chemotherapy-induced nausea and vomiting despite standard antiemetic prophylaxis, but was associated with additional ...
Efficacy of cannabinoids for the prophylaxis ...
Background Cannabinoids have potential efficacy as prophylaxis for chemotherapy-induced nausea and vomiting (CINV), but no recent meta ...
Medical Cannabis for Nausea in Patients Receiving ...
This study will evaluate whether medical cannabis can reduce nausea in adults receiving moderately or highly nausea-causing chemotherapy.
Cannabis for Chemotherapy-induced Nausea and Vomiting
Preliminary findings suggest this regimen was associated with less nausea and vomiting but additional side effects.11,12; Some cannabinoid side effects may be ...
medicinal cannabis
High-THC medicinal cannabis products can sometimes be effective for nausea and vomiting and should only be prescribed only after newer standard approved ...
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