Assessing Benefits and Harms of Cannabis and Cannabinoid Use Among a Cohort of Cancer Patients Treated in Community Oncology Clinics

评估在社区肿瘤诊所接受治疗的一组癌症患者中大麻和大麻素使用的益处和危害

• 批准号: 10792076
• 负责人: BETH A. REBOUSSIN
• 金额: $ 67万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-21 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10792076
• 关键词: Acute; Address; Adult; Adverse effects; Affect; Age; Anxiety; Benefits and Risks; Cancer Patient; Cannabinoids; Cannabis; Cannabis policy; Cannabis retail; Characteristics; Clinic; Clinical; Clinical Trials; Collaborations; Colorectal Cancer; Communities; Community Clinical Oncology Program; Community Networks; Complex; Coupled; Cross-Sectional Studies; Data; Diagnosis; Dose; Drug Interactions; Drug Prescriptions; Effectiveness; Engineering; Environment; Ethnic Origin; Fatigue; Frequencies; Future; Goals; Hematology; Hepatotoxicity; Heterogeneity; Immune checkpoint inhibitor; Immune response; Immunosuppression; Individual; Inflammatory; Interferon Type II; Intoxication; Kidney; Legal; Licensing; Life; Liver; Longitudinal Studies; Lymphocyte; Lymphocyte Count; Malignant Neoplasms; Malignant neoplasm of lung; Marketing; Measures; Medicine; Metabolism; National Cancer Institute; Nausea and Vomiting; Neuropathy; Newly Diagnosed; Non-Hodgkin' s Lymphoma; Non-Small-Cell Lung Carcinoma; Opioid; Outcome; Participant; Patient Recruitments; Patients; Pattern; Perception; Pharmaceutical Preparations; Plasma; Population; Prevalence; Provider; Quality of life; Race; Recommendation; Recording of previous events; Recreation; Regimen; Regulation; Reporting; Research; Risk; Role; Rural; Sample Size; Sampling; Serious Adverse Event; Severities; Smoke; Subgroup; Surveys; Symptoms; Therapeutic; Time; Toxic effect; Treatment-related toxicity; Uncertain Risk; United States National Academy of Sciences; active method; associated symptom; cancer care; cancer therapy; cannabis use behavior; chemotherapy; clinical practice; cohort; community-level factor; comorbidity; design; disabling symptom; dosage; experience; improved; inflammatory marker; inter-individual variation; malignant breast neoplasm; marijuana legalization; marijuana use; marijuana user; melanoma; neuropsychiatric symptom; pharmacokinetics and pharmacodynamics; physical symptom; programs; recruit; reduce symptoms; sex; symptom management; tumor; vaping

SUMMARY Cancer patients suffer from a multitude of debilitating symptoms associated with cancer and cancer treatment, many of which are not relieved with prescription medications. In hopes of managing these symptoms, many patients are turning to cannabis, with recent estimates of cannabis use among cancer patients ranging from 24-40%, primarily for physical and neuropsychiatric symptom relief, despite limited evidence of benefits and uncertain risks. This is, in part, due to increased availability of cannabis as more states legalize use. The expanding cannabis market, with varying regulations, limited product standards and few marketing restrictions, has resulted in a marketplace filled with diverse product types (e.g., smoked cannabis, vapes, edibles, topicals) with unpredictable cannabinoid concentrations, often exceeding that of therapeutic benefit (THC>15%). These products are associated with acute intoxicating effects and long-term adverse effects. Furthermore, THC and CBD, the primary cannabinoids, may be hepatotoxic, affect the metabolism of chemotherapy, and result in drug interactions that could enhance chemotoxicity. Furthermore, cannabis’ immunosuppressive effects could dampen immune responses and alter the efficacy of immune checkpoint inhibitors. Despite this, patients generally report that cannabis improves cancer-related symptoms. Current evidence for clinical benefits of cannabis is mixed and often inconclusive, largely due to small sample sizes and/or cross-sectional data. To better understand the benefits and risks of cannabis and cannabinoid use during cancer treatment, rigorous longitudinal studies of patient cohorts that document details of cannabis use (i.e. product type, frequency, cannabinoid ratios and potency, and patterns of use) are needed. We aim to achieve this goal by collaborating with the National Cancer Institute Community Oncology Research Program (NCORP), a national network of community oncology clinics. We will recruit a sample of 2000 newly diagnosed cancer patients with breast cancer, non-small cell lung cancer, colorectal cancer, melanoma, or non-Hodgkin lymphoma, to assess the benefits and risks of cannabis and cannabinoid use during treatment. Participants will complete monthly online surveys for 12 months to assess cancer-related symptoms and severity, as well as detailed cannabis and cannabinoid use. This will allow us to (1) describe the longitudinal patterns of use among adult cancer patients during treatment and the effect of individual, clinical and community-level factors on these patterns, and (2) determine the potential benefits and harms of use on cancer and treatment-related symptoms (e.g., nausea/ vomiting, anxiety, neuropathy). We will also assess potential pharmacokinetic and pharmacodynamic effects of use with cancer treatment and changes in inflammatory and toxicity markers by collecting and analyzing biospecimens in a subgroup of lung cancer patients. These data will provide a better understanding of the temporal relationship between heterogeneous patterns of cannabis and cannabinoid use and cancer symptom management; information that will contribute significantly to the design of future clinical trials in cancer care.

概括 癌症患者患有多种与癌症和癌症治疗相关的令人衰弱的症状， 其中许多没有处方药缓解。希望管理这些符号，许多 患者正在转向大麻，最近估计的癌症患者中使用大麻 24-40％，主要用于身体和神经精神症状缓解，目的地有限的福利证据和 不确定的风险。这部分是由于大麻的可用性增加，因为越来越多的州合法使用使用。这 扩大大麻市场，具有不同的法规，有限的产品标准和少数营销限制， 导致了一个充满潜水产品类型的市场（例如，烟熏大麻，vapes，Edibles，hoticals） 具有不可预测的大麻素浓度，通常超过治疗益处的浓度（THC> 15％）。这些 产品与急性醉酒作用和长期不利影响有关。此外，THC和 CBD是主要的大麻素，可能是肝毒性的，会影响化学疗法的代谢，并导致 可以增强趋化性的药物相互作用。此外，大麻的免疫抑制作用可能 该死的免疫反应并改变免疫检查点抑制剂的效率。尽管如此，病人 通常报告大麻改善了与癌症相关的症状。目前证明临床益处​​的证据 大麻是混合的，通常尚无定论，这主要是由于样本量和/或横截面数据很小。到 更好地了解癌症治疗期间大麻和大麻素的好处和风险 患者同类群的纵向研究记录了大麻使用细节（即产品类型，频率， 需要大麻素的比率和效力，以及使用模式）。我们旨在通过合作来实现这一目标 与国家癌症研究所社区肿瘤研究计划（NCORP）一起，国家网络 社区肿瘤学诊所。我们将招募2000个新诊断的乳腺癌患者的样本 癌症，非小细胞肺癌，大肠癌，黑色素瘤或非霍奇金淋巴瘤，以评估 治疗过程中大麻和大麻素使用的好处和风险。参与者将每月在线完成 调查12个月以评估与癌症有关的符号和严重性，以及详细的大麻和 大麻素的使用。这将使我们能够（1）描述成人癌症患者的纵向使用模式 在治疗期间以及个人，临床和社区水平因素对这些模式的影响，（2） 确定使用对癌症和治疗相关符号的潜在益处和危害（例如恶心/ 呕吐，焦虑，神经病）。我们还将评估潜在的药代动力学和药效动力学作用 通过收集和分析，用于癌症治疗以及炎症和毒性标记的变化 肺癌患者亚组中的生物测量。这些数据将更好地理解 大麻与大麻素的异质模式与癌症症状之间的临时关系 管理;将对未来的癌症护理临床试验设计产生重大贡献的信息。