Medical Cannabis Observational Study for Antiemetic Intervention in Chemotherapy

NCT07374939 | Not Yet Recruiting DMC

• 1 other identifier: STUDY00011238
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nausea and Vomiting Chemotherapy-Induced

Keywords

medical cannabis; chemotherapy-induced nausea and vomiting; nausea; nausea and vomiting

Outcome Measures

Primary Outcomes (2)

• Average and Maximum Nausea Severity as Measured by the Nausea and Vomiting Diary

  Average nausea severity will be measured using a participant completed nausea and vomiting diary. Nausea severity is rated on an 11 point numeric scale anchored by "Not at all nauseated" (0) and "Extremely nauseated" (10). Average nausea is calculated as the mean of up to 15 assessment points, including afternoon, evening, and night on Day 1 and morning, afternoon, evening, and night on Days 2 through 4. Higher scores indicate greater nausea severity. Scores will be set to missing if 11 or more of the 15 assessments are missing. Maximum nausea severity will be measured using a participant-completed nausea and vomiting diary. Nausea severity is rated on an 11-point numeric scale anchored by "Not at all nauseated" (0) and "Extremely nauseated" (10). Maximum nausea is defined as the highest nausea rating reported across the same 15 assessment points.

  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)

• Number of Emesis Episodes Recorded in the Nausea and Vomiting Diary

  Emesis episodes will be recorded daily by participants using the nausea and vomiting diary. The outcome is the total number of vomiting episodes recorded during the assessment period.

  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)

Secondary Outcomes (19)

• Complete Protection From Chemotherapy Induced Nausea and Vomiting

  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)

• Complete Control of Chemotherapy Induced Nausea and Vomiting

  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)

• Complete Response to Chemotherapy Induced Nausea and Vomiting

  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)

• Change in Appetite as Measured by the University of Rochester Cancer Center (URCC) Symptom Inventory

  Baseline (within 7 days before chemotherapy) and Day 4 following chemotherapy during Cycles 1 and 3; post-cycle questionnaires completed on Day 4 or within 48 hours (Day 1 defined as the day of chemotherapy administration; cycles are 14-28 days).

• Change in Appetite Related Quality of Life as Measured by the Functional Assessment of Anorexia Cachexia Therapy Questionnaire

  Baseline (within 7 days before chemotherapy) and Day 4 following chemotherapy during Cycles 1 and 3; post-cycle questionnaires completed on Day 4 or within 48 hours (Day 1 defined as the day of chemotherapy administration; cycles are 14-28 days).

Study Arms (2)

Cannabis Use Group

Participants who independently choose to obtain and use Medical Cannabis during chemotherapy.

Drug: Medical Cannabis

Standard Care Group

Participants who choose not to use cannabis and continue with antiemetic therapy as prescribed by their oncology care team.

Interventions

Medical Cannabis DRUG

Participant-directed medical cannabis use

Cannabis Use Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The MOSAIC study aims to enroll 50 participants. The study population consists of both males and females, aged 21 years or older, who are initiating first-line moderately or highly emetogenic chemotherapy, as defined by MASCC/NCCN criteria. Participants must be able to understand and communicate in English, and meet the various inclusion and exclusion criteria to be enrolled into this study.

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

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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Central Study Contacts

Luke Peppone, PhD

CONTACT

585-275-7827; Luke_Peppone@URMC.Rochester.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Department of Surgery, Cancer Control (SMD)

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)