Nausea and Vomiting Chemotherapy-InducedMOSAICNCT07374939
Medical Cannabis Observational Study for Antiemetic Intervention in Chemotherapy
An observational study of Nausea and Vomiting Chemotherapy-Induced, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Nausea and Vomiting Chemotherapy-Induced
- What is being tested?
- Medical Cannabis
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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
- Dual-drug liposomal encapsulation of cytarabine and daunorubicin
- Dinutuximab
- Doxorubicind <60 mg/m2
- Epirubicind ≤90 mg/m2
- Idarubicin
- Ifosfamided <2 g/m2 per dose
- Interferon alfa ≥10 million IU/m2
- Irinotecan
- Irinotecan (liposomal)
- Melphalan
- Methotrexated ≥250 mg/m2
- Oxaliplatin
- Temozolomide
- Trabectedin
- Be willing to commit to the suggested medication dosing and delivery method, completing evaluation instruments, and attending all study visits.
- Be able to understand English (all assessment instruments are in English).
- Be 21 years of age or older.
- Give informed consent.
- Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, or abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
Luke J Peppone, PhD, 5852757827, luke_peppone@urmc.rochester.edu
Liz Schifano, MSW, 585-275-0690, elizabeth_schifano@urmc.rochester.edu
About this study
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?
Read more
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.
Read the detailed description
Many people receiving chemotherapy experience nausea, even when they are given standard anti-nausea medications. Vomiting is now often well controlled, but nausea, especially nausea that occurs one or more days after chemotherapy, remains a major problem. Nausea can interfere with daily activities, reduce appetite, worsen quality of life, and sometimes lead to dehydration or delays in cancer treatment. New approaches are needed to better manage chemotherapy-related nausea.
Medical cannabis is commonly used by patients to help with nausea, appetite, sleep, pain, and other treatment-related symptoms. Although cannabis is legal for medical use in many U.S. states and cancer is a qualifying condition, there is limited scientific evidence about how well cannabis works for chemotherapy-related nausea when used alongside modern anti-nausea medications. More research is needed to understand its benefits, risks, and how it may best be used.
The purpose of this study is to examine the associations between patient-directed medical cannabis use and chemotherapy-related symptoms in adults receiving moderately or highly nausea-causing chemotherapy. The study will also evaluate associations between medical cannabis use and vomiting, appetite, fatigue, sleep, pain, nerve pain, mood, and quality of life. In addition, blood samples will be collected to explore whether medical cannabis use is associated with changes in inflammation related to cancer treatment.
About 50 adults with cancer who are receiving chemotherapy will take part in this study at the University of Rochester Medical Center. Participants must be 21 years of age or older and receiving chemotherapy that commonly causes nausea. People with certain medical or psychiatric conditions, recent cannabis use, history of stroke, TIA, COPD, or lung disease may be excluded based on study eligibility criteria.
All participants will determine if they wish to use medical cannabis as part of their routine symptom management independently, or in consultation with their oncologist. The study will observe and compare the symptom outcomes between participants who use medical cannabis and those who do not.
The study will not provide, prescribe, or direct the use of medical cannabis. Decisions regarding medical cannabis use will be made by participants and their medical team. Participants will keep daily diaries to record nausea, vomiting, cannabis use (if applicable), and any side effects. They will also complete questionnaires about symptoms, mood, and quality of life. Blood samples will be collected once per chemotherapy cycle during routine lab visits.
Possible risks include minor risks from blood draws such as bruising or lightheadedness. There is no direct benefit to participants in trial participation, but the information gained may help improve nausea management for future cancer patients.
This study will provide important early evidence about the relationship between medical cannabis use and chemotherapy-related nausea symptoms such as nausea, vomiting, appetite, fatigue, sleep, pain, and quality of life. This will help guide larger future clinical trials.
- Conditions
- Nausea and Vomiting Chemotherapy-Induced
- Being tested
- Medical Cannabis
- Keywords
- medical cannabis, chemotherapy-induced nausea and vomiting, nausea, nausea and vomiting
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical CannabisDrug
Participant-directed medical cannabis use
| Study group | Role | What they receive |
|---|---|---|
| Cannabis Use Group | Participants who independently choose to obtain and use Medical Cannabis during chemotherapy. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Complete protection is defined as no emesis, no use of additional rescue therapy, and no significant nausea defined as a nausea score of 2 or less on a 0 to 10 numeric rating scale. The outcome will be reported as the proportion of participants meeting these criteria.
Measured: 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
Complete control is defined as no emesis, no use of additional rescue therapy, and no nausea defined as a nausea score of 0 on a 0 to 10 numeric rating scale.
Measured: 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
Complete response is defined as no emesis and no use of additional rescue therapy. The outcome will be reported as the proportion of participants meeting these criteria.
Measured: 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
Appetite will be assessed using the URCC Symptom Inventory. Appetite is measured on an 11 point numeric scale anchored by "Not at all hungry" (0) and "Extremely hungry" (10). Higher scores indicate greater appetite.
Measured: 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
Appetite related quality of life will be measured using the Functional Assessment of Anorexia Cachexia Therapy questionnaire, a validated instrument designed to assess quality of life and anorexia or cachexia related concerns. Higher scores indicate better appetite related quality of life.
Measured: 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 Anxiety Severity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form
Anxiety severity will be measured using the PROMIS Anxiety Short Form. PROMIS T scores are standardized to a mean of 50 and a standard deviation of 10, with higher scores indicating greater anxiety severity.
Measured: 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 Depressive Symptoms as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form
Depressive symptoms will be measured using the PROMIS Depression Short Form. PROMIS T scores are standardized to a mean of 50 and a standard deviation of 10, with higher scores indicating greater depressive symptom severity.
Measured: 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 Fatigue as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form
Fatigue severity will be measured using the PROMIS Fatigue Short Form. PROMIS T scores are standardized to a mean of 50 and a standard deviation of 10, with higher scores indicating greater fatigue severity.
Measured: 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 Pain Interference as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form
Pain interference will be measured using the PROMIS Pain Interference Short Form. PROMIS T scores are standardized to a mean of 50 and a standard deviation of 10, with higher scores indicating greater pain interference.
Measured: 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 Physical Function as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form
Physical function will be measured using the PROMIS Physical Function Short Form. PROMIS T scores are standardized to a mean of 50 and a standard deviation of 10, with higher scores indicating better physical function.
Measured: 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 Sleep Disturbance as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form
Sleep disturbance will be measured using the PROMIS Sleep Disturbance Short Form. PROMIS T scores are standardized to a mean of 50 and a standard deviation of 10, with higher scores indicating greater sleep disturbance.
Measured: 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 Ability to Participate in Social Roles and Activities as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form
Ability to participate in social roles and activities will be measured using the PROMIS Ability to Participate in Social Roles and Activities Short Form. PROMIS T scores are standardized to a mean of 50 and a standard deviation of 10, with higher scores indicating better social participation.
Measured: 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 Pain Intensity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Item
Pain intensity will be measured using a single PROMIS pain intensity item rated on a numeric scale ranging from 0 no pain to 10 worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: 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 Cognitive Function as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Short Form
Perceived cognitive function will be measured using the PROMIS Cognitive Function Short Form. PROMIS T scores are standardized with higher scores indicating better cognitive function.
Measured: 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 Concerns About Death and Dying as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Health-Related Quality of Life in Neurological Disorders (HDQLIFE) Concern With Death and Dying Scale
Concerns related to death and dying will be measured using the PROMIS HDQLIFE Concern With Death and Dying Short Form. Higher scores indicate greater concern.
Measured: 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 Health Related Quality of Life as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Preference Summary Score
Health related quality of life will be measured using the PROMIS Preference summary score, a preference based utility score derived from multiple PROMIS domains and calculated using the MultiAttribute Utility Theory method. Higher scores indicate better health related quality of life.
Measured: 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 Peripheral Neuropathic Pain as Measured by the EORTC CIPN 20 Questionnaire
Peripheral neuropathic pain will be measured using the European Organisation for Research and Treatment of Cancer Chemotherapy Induced Peripheral Neuropathy 20 item questionnaire. Higher scores indicate greater neuropathic symptom severity.
Measured: 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 Psychological Distress as Measured by the NCCN Distress Thermometer
Psychological distress will be measured using the National Comprehensive Cancer Network Distress Thermometer, an 11 point scale ranging from 0 no distress to 10 extreme distress. Higher scores indicate greater distress.
Measured: Baseline (within 7 days before chemotherapy) to Day 4 after chemotherapy during up to 3 cycles; post-cycle questionnaires completed on Day 4 or within 48 hours (Day 1 = chemotherapy; cycles 14-28 days).
Subjective Drug Effects as Measured by the Drug Effects Questionnaire
Subjective drug effects will be measured using the Drug Effects Questionnaire, which assesses perceived strength of substance effects and desirability of substance effects using numeric rating scales. Higher scores indicate stronger or more desirable subjective effects.
Measured: Day 4 following chemotherapy during Cycle 3 only; questionnaire completed on Day 4 or within 48 hours thereafter (Day 1 defined as the day of chemotherapy administration; cycles are 14-28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting Chemotherapy-InducedStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luke Peppone, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374939
- Sponsor's protocol ID
- STUDY00011238
- Acronym
- MOSAIC
- Status last verified
- Jun 2026
- First submitted
- 16 Jan 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the primary and secondary outcome analyses will be made available upon reasonable request. Shared data will include analyzable datasets necessary to reproduce reported results.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Cannabis Observational Study for Antiemetic Intervention in Chemotherapy
- ClinicalTrials.gov ID
- NCT07374939
- Acronym / sponsor ID
- MOSAIC / STUDY00011238
- Conditions
- Nausea and Vomiting Chemotherapy-Induced
- Keywords
- medical cannabis, chemotherapy-induced nausea and vomiting, nausea, nausea and vomiting
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Many people receiving chemotherapy experience nausea, even when they are given standard anti-nausea medications. Vomiting is now often well controlled, but nausea, especially nausea that occurs one or more days after chemotherapy, remains a major problem. Nausea can interfere with daily activities, reduce appetite, worsen quality of life, and sometimes lead to dehydration or delays in cancer treatment. New approaches are needed to better manage chemotherapy-related nausea.
Medical cannabis is commonly used by patients to help with nausea, appetite, sleep, pain, and other treatment-related symptoms. Although cannabis is legal for medical use in many U.S. states and cancer is a qualifying condition, there is limited scientific evidence about how well cannabis works for chemotherapy-related nausea when used alongside modern anti-nausea medications. More research is needed to understand its benefits, risks, and how it may best be used.
The purpose of this study is to examine the associations between patient-directed medical cannabis use and chemotherapy-related symptoms in adults receiving moderately or highly nausea-causing chemotherapy. The study will also evaluate associations between medical cannabis use and vomiting, appetite, fatigue, sleep, pain, nerve pain, mood, and quality of life. In addition, blood samples will be collected to explore whether medical cannabis use is associated with changes in inflammation related to cancer treatment.
About 50 adults with cancer who are receiving chemotherapy will take part in this study at the University of Rochester Medical Center. Participants must be 21 years of age or older and receiving chemotherapy that commonly causes nausea. People with certain medical or psychiatric conditions, recent cannabis use, history of stroke, TIA, COPD, or lung disease may be excluded based on study eligibility criteria.
All participants will determine if they wish to use medical cannabis as part of their routine symptom management independently, or in consultation with their oncologist. The study will observe and compare the symptom outcomes between participants who use medical cannabis and those who do not.
The study will not provide, prescribe, or direct the use of medical cannabis. Decisions regarding medical cannabis use will be made by participants and their medical team. Participants will keep daily diaries to record nausea, vomiting, cannabis use (if applicable), and any side effects. They will also complete questionnaires about symptoms, mood, and quality of life. Blood samples will be collected once per chemotherapy cycle during routine lab visits.
Possible risks include minor risks from blood draws such as bruising or lightheadedness. There is no direct benefit to participants in trial participation, but the information gained may help improve nausea management for future cancer patients.
This study will provide important early evidence about the relationship between medical cannabis use and chemotherapy-related nausea symptoms such as nausea, vomiting, appetite, fatigue, sleep, pain, and quality of life. This will help guide larger future clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis Use Group | – | Drug: Medical CannabisParticipants who independently choose to obtain and use Medical Cannabis during chemotherapy. |
| Standard Care Group | – | –Participants who choose not to use cannabis and continue with antiemetic therapy as prescribed by their oncology care team. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (52 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical CannabisParticipant-directed medical cannabis use | Drug | Cannabis Use Group |
Primary outcome
Average and Maximum Nausea Severity as Measured by the Nausea and Vomiting Diary
Time frame: 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)
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.
Number of Emesis Episodes Recorded in the Nausea and Vomiting Diary
Time frame: 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)
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.
19 secondary outcomes
Complete Protection From Chemotherapy Induced Nausea and Vomiting
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Anxiety Severity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form
Time frame: 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 Depressive Symptoms as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form
Time frame: 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 Fatigue as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form
Time frame: 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 Pain Interference as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form
Time frame: 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 Physical Function as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form
Time frame: 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 Sleep Disturbance as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form
Time frame: 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 Ability to Participate in Social Roles and Activities as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form
Time frame: 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 Pain Intensity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Item
Time frame: 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 Cognitive Function as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Short Form
Time frame: 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 Concerns About Death and Dying as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Health-Related Quality of Life in Neurological Disorders (HDQLIFE) Concern With Death and Dying Scale
Time frame: 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 Health Related Quality of Life as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Preference Summary Score
Time frame: 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 Peripheral Neuropathic Pain as Measured by the EORTC CIPN 20 Questionnaire
Time frame: 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 Psychological Distress as Measured by the NCCN Distress Thermometer
Time frame: Baseline (within 7 days before chemotherapy) to Day 4 after chemotherapy during up to 3 cycles; post-cycle questionnaires completed on Day 4 or within 48 hours (Day 1 = chemotherapy; cycles 14-28 days).
Subjective Drug Effects as Measured by the Drug Effects Questionnaire
Time frame: Day 4 following chemotherapy during Cycle 3 only; questionnaire completed on Day 4 or within 48 hours thereafter (Day 1 defined as the day of chemotherapy administration; cycles are 14-28 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the primary and secondary outcome analyses will be made available upon reasonable request. Shared data will include analyzable datasets necessary to reproduce reported results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nausea and Vomiting Chemotherapy-Induced, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 52 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luke Peppone, PhD (585-275-7827, Luke_Peppone@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average and Maximum Nausea Severity as Measured by the Nausea and Vomiting Diary (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.