Medical Cannabis Observational Study for Antiemetic Intervention in Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medical Cannabis.
- Who it may be relevant to
- Registry conditions: Nausea and Vomiting Chemotherapy-Induced. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Medical Cannabis
Participant-directed medical cannabis use
Primary outcome measures
- 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)]
- 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)]
Secondary outcome measures (12)
- 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).]
Eligibility criteria
Inclusion criteria
- Have a diagnosis of cancer with no previous chemotherapy treatments (aside from current treatment)
- Be scheduled to receive treatment with a chemotherapeutic agent that is classified by the National Comprehensive Cancer Network (NCCN) as having a high emetogenic potential (>90% incidence) or moderate emetogenic potential (30-90% incidence).
- Must be scheduled for a minimum of 3 additional chemotherapy cycles at the time of enrollment.
- Chemotherapy agents may be given intravenously or orally.
- Chemotherapy cycles must be at least two weeks apart.
- For the purposes of this study, Day 1 is defined as the day of chemotherapy administration.
- Chemotherapy may be for adjuvant, neoadjuvant, curative, or palliative intent.
- Highly emetogenic - common types of chemotherapy
- AC combination defined as any chemotherapy regimen that contains an anthracycline and cyclophosphamide
- Carboplatin AUC ≥4
- Carmustine >250 mg/m2
- Cisplatin
- Cyclophosphamide >1,500 mg/m2
- Dacarbazine
- Doxorubicin ≥60 mg/m2
- 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.
Exclusion criteria
- Participants must not:
- Use of any THC-containing cannabis products within 30 days prior to enrollment, verified by participant self-report.
Allowable: Use of hemp-derived CBD products containing < 0.3 % THC is permitted, consistent with the 2018 Agriculture Improvement Act (federal definition of hemp). Use of CBD products will be documented in baseline case report forms.
- Have any allergies to cannabis or contraindication for cannabis.
- Have an active or recent (< 6 months) substance use disorder, as determined by medical history.
- Have recently quit smoking (< 6 months) or are actively engaged in a smoking-cessation program.
- Have a history of severe anxiety or paranoia on prior exposure to cannabis.
- Have a previous diagnosis of bipolar disorder or schizophrenia.
- Be pregnant or nursing.
- Have had a prior stroke.
- Have moderate or severe chronic obstructive pulmonary disease (COPD), defined as FEV₁ < 50 % predicted or current use of home supplemental oxygen.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Rochester Medical Center — Rochester
Identifiers
NCT: NCT07374939 · STUDY00011238