Medical Cannabis
Participant-directed medical cannabis use
Loading study record…
Loading study record…
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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-06-09
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Participant-directed medical cannabis use
Eligibility
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.
primary outcomes
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.
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.
secondary outcomes
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 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 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 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: 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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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) 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).
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: 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).
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.
Publications
No exact PMID-linked public article is currently readable locally.