Medical Cannabis Observational Study for Antiemetic Intervention in Chemotherapy

Starting soon

Conditions studied: Nausea and Vomiting Chemotherapy-Induced

In brief

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 facts

Study ID

NCT07374939

Run by

University of Rochester

People needed

50

Starts

2026-09-01

Expected to finish

2028-03-01

Last updated by the study team

2026-06-09

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 of this study, Day 1 is defined as the day of chemotherapy administration.
• Chemotherapy may be for adjuvant, neoadjuvant, curative, or palliative intent.
• Highly emetogenic - common types of chemotherapy
• AC combination defined as any chemotherapy regimen that contains an anthracycline and cyclophosphamide
• Carboplatin AUC ≥4
• Carmustine >250 mg/m2
• Cisplatin
• Cyclophosphamide >1,500 mg/m2
• Dacarbazine
• Doxorubicin ≥60 mg/m2
• Epirubicin >90 mg/m2
• Ifosfamide ≥2 g/m2 per dose
• Mechlorethamine
• Streptozocin
• Moderately emetogenic - common types of chemotherapy:
• Aldesleukin >12-15 million IU/m2
• Amifostine >300 mg/m2
• Arsenic trioxide
• Azacitidine
• Bendamustine

You may not qualify if…

• Participants must not:
• Use of any THC-containing cannabis products within 30 days prior to enrollment, verified by participant self-report.
• Allowable: Use of hemp-derived CBD products containing < 0.3 % THC is permitted, consistent with the 2018 Agriculture Improvement Act (federal definition of hemp). Use of CBD products will be documented in baseline case report forms.
• Have any allergies to cannabis or contraindication for cannabis.
• Have an active or recent (< 6 months) substance use disorder, as determined by medical history.
• Have recently quit smoking (< 6 months) or are actively engaged in a smoking-cessation program.
• Have a history of severe anxiety or paranoia on prior exposure to cannabis.
• Have a previous diagnosis of bipolar disorder or schizophrenia.
• Be pregnant or nursing.
• Have had a prior stroke.
• Have moderate or severe chronic obstructive pulmonary disease (COPD), defined as FEV₁ < 50 % predicted or current use of home supplemental oxygen.

Where it is running

• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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