Medical Cannabis Observational Study for Antiemetic Intervention in Chemotherapy (NCT07374939) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Medical Cannabis Observational Study for Antiemetic Intervention in Chemotherapy
United States50 participantsStarted 2026-09-01
Plain-language summary
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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
* Busulfan
* Carboplatin AUC \<4
* Carmustined ≤250 mg/m2
* Clofarabine
* Cyclophosphamide ≤1500 mg/m2
* Cytarabine \>200 mg/m2
* Dactinomycin
* Daunorubicin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average and Maximum Nausea Severity as Measured by the Nausea and Vomiting Diary
Timeframe: Days 1-4 following chemotherapy administration during up to 3 on-study chemotherapy cycles (Day 1 defined as the day of chemotherapy administration; each chemotherapy cycle is 14-28 days, depending on regimen)
2
Number of Emesis Episodes Recorded in the Nausea and Vomiting Diary
Timeframe: Days 1-4 following chemotherapy administration during up to 3 on-study chemotherapy cycles (Day 1 defined as the day of chemotherapy administration; each chemotherapy cycle is 14-28 days, depending on regimen)