Medical Cannabis Observational Study for Antiemetic Intervention in Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Average and Maximum Nausea Severity as Measured by the Nausea and Vomiting Diary
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
- 另有 1 项未显示
排除标准
- •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.
研究组 & 干预措施
Immediate use
Participants randomized to the Immediate Use arm will receive New York State medical cannabis certification and initiate medical cannabis use during their first on-study chemotherapy cycle, in addition to standard guideline-recommended antiemetic therapy. Participants will use medical cannabis primarily during the four days surrounding chemotherapy administration, corresponding to the acute and delayed nausea period. Cannabis will be administered by vaporization using a standardized device, dose limits, and schedule. Participants will complete daily nausea and vomiting diaries, cannabis use logs, and symptom questionnaires, and will provide blood samples once per chemotherapy cycle. Outcomes in this arm will be compared to the delayed-use arm to evaluate the preliminary efficacy, safety, and feasibility of medical cannabis for chemotherapy-related nausea.
干预措施: Medical Cannabis (Drug)
Delayed use
Participants randomized to the Delayed Use arm will receive standard guideline-recommended antiemetic therapy alone during their first on-study chemotherapy cycle and will not use medical cannabis during this initial evaluation period. This cycle will serve as the comparison condition for nausea outcomes. After completion of the first cycle assessments, participants will receive New York State medical cannabis certification and will initiate medical cannabis use during the subsequent chemotherapy cycle. Cannabis will be administered by vaporization using a standardized device, dose limits, and schedule, primarily during the four days surrounding chemotherapy administration. Participants will complete daily nausea and vomiting diaries, cannabis use logs, symptom questionnaires, and provide blood samples once per chemotherapy cycle to evaluate changes after cannabis initiation.
干预措施: Medical Cannabis (Drug)
结局指标
主要结局
Average and Maximum Nausea Severity as Measured by the Nausea and Vomiting Diary
时间窗: 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
时间窗: 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.
次要结局
- Complete Protection From Chemotherapy Induced Nausea and Vomiting(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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).)
研究者
Luke Peppone
Associate Professor - Department of Surgery, Cancer Control (SMD)
University of Rochester