Medical Cannabis Observational Study for Antiemetic Intervention in Chemotherapy

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.

• Complete Protection From Chemotherapy Induced Nausea and Vomiting [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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).]