Medical Cannabis for Nausea in Patients Receiving Moderately or Highly Emetogenic Chemotherapy

NCT07374939 | Not Yet Recruiting Phase 2 DMC

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

Brief Summary

Many people receiving chemotherapy experience nausea despite standard anti-nausea medications. Medical cannabis is commonly used to help manage nausea, but there is limited scientific evidence about its effectiveness when used alongside modern chemotherapy treatments. This study will evaluate whether medical cannabis can reduce nausea in adults receiving moderately or highly nausea-causing chemotherapy. Participants will be randomly assigned to start medical cannabis either immediately or after one chemotherapy cycle, allowing comparison of symptoms with and without cannabis use. All participants will continue their usual anti-nausea medications. The study will also examine effects on vomiting, appetite, pain, fatigue, sleep, mood, quality of life, and inflammation. Results from this pilot study will help determine the safety, feasibility, and potential benefits of medical cannabis for chemotherapy-related nausea and guide future larger clinical trials.

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)

Immediate use

EXPERIMENTAL

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.

Drug: Medical Cannabis

Delayed use

ACTIVE COMPARATOR

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.

Drug: Medical Cannabis

Interventions

Medical Cannabis DRUG

Medical cannabis will be used as an adjunct to standard guideline-recommended antiemetic therapy for chemotherapy-related nausea. Participants will obtain state-certified medical cannabis products through a New York State-licensed dispensary and self-administer cannabis via vaporization using a standardized device. Dose limits and timing of use will be guided by the study protocol to promote consistency while allowing individualized use. Medical cannabis will be used during the acute and delayed nausea period, defined as Days 1 through 4 following chemotherapy administration. Participants randomized to the Immediate Use arm will initiate cannabis use during their first on-study chemotherapy cycle, whereas participants randomized to the Delayed Use arm will initiate cannabis use after completion of the first cycle. Cannabis use patterns, nausea and vomiting symptoms, adverse effects, and patient-reported outcomes will be recorded using participant-completed diaries and questionnaires.

Delayed use; Immediate use

Eligibility Criteria

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

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: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• 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: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)