Medical Cannabis Observational Study for Antiemetic Intervention in Chemotherapy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Use of any THC-containing cannabis products within 30 days prior to enrollment, verified by participant self-report.
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.
Trial design
Treatments tested in this trial
- Medical Cannabis
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov