An observational study in Nausea and Vomiting Chemotherapy-Induced, sponsored by University of Rochester. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by University of Rochester · Observational
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:
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.
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.
644 studies on the registry are indexed under Nausea; 85 are open to participants now.
This study's planned enrollment of 50 is below the median of 204 across 68 observational studies indexed under Nausea.
Browse Nausea studies →University of Rochester is the lead sponsor of 729 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Highly emetogenic - common types of chemotherapy
Moderately emetogenic - common types of chemotherapy:
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who independently choose to obtain and use Medical Cannabis during chemotherapy.
Drug: Medical Cannabis
Participants who choose not to use cannabis and continue with antiemetic therapy as prescribed by their oncology care team.
Participant-directed medical cannabis use
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.
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)
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.
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 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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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).
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Mar 2028, 18 months later.
Of 28 observational studies under Nausea, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 48. This study's planned 18 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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