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.

总结 癌症患者遭受与癌症和癌症治疗相关的多种衰弱症状， 其中许多不能用处方药缓解。为了控制这些症状，许多人 患者正在转向大麻，最近估计癌症患者中大麻的使用范围从 24- 40%，主要用于缓解身体和神经精神症状，尽管益处的证据有限， 不确定的风险。部分原因是随着更多的州将大麻合法化，大麻的供应量增加。的 * 大麻市场不断扩大，但法规各异，产品标准有限，销售限制很少， 导致市场充满了不同的产品类型（例如，吸食大麻、电子烟、食品、外用药） 大麻素浓度不可预测，通常超过治疗益处（THC>15%）。这些 产品与急性中毒效应和长期不良效应有关。此外，THC和 CBD，主要的大麻素，可能是肝毒性的，影响化疗的代谢，并导致 药物相互作用可能会增强化疗毒性。此外，大麻的免疫抑制作用可能 抑制免疫反应并改变免疫检查点抑制剂的功效。尽管如此，患者 一般报告说，大麻改善癌症相关症状。目前的临床获益证据 大麻的情况参差不齐，而且往往没有定论，这主要是由于样本量小和（或）跨部门数据。到 更好地了解癌症治疗期间使用大麻和大麻素的益处和风险，严格 对记录大麻使用细节（即产品类型，频率， 大麻素的比例和效力以及使用模式）。我们的目标是通过合作来实现这一目标。 与国家癌症研究所社区肿瘤学研究计划（NCORP），一个全国性的网络， 社区肿瘤诊所我们将招募2000名新诊断的乳腺癌患者作为样本， 癌症、非小细胞肺癌、结直肠癌、黑色素瘤或非霍奇金淋巴瘤，以评估 治疗期间使用大麻和大麻素的益处和风险。参与者将每月在线完成 为期12个月的调查，以评估癌症相关的症状和严重程度，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 治疗期间以及个人、临床和社区层面因素对这些模式的影响，以及（2） 确定使用对癌症和治疗相关症状的潜在益处和危害（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学效应 以及炎症和毒性标志物的变化， 肺癌患者亚组中的生物样本。这些数据将有助于更好地了解 大麻和大麻素使用异质模式与癌症症状时间关系 管理;信息，这将有助于显着的设计，未来的临床试验在癌症护理。