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衰弱症状， 许多人无法通过处方药缓解这些症状。 患者正在转向大麻，最近估计癌症患者使用大麻的范围从 24-40%，主要是为了缓解身体和神经精神症状，尽管益处和证据有限 这在一定程度上是由于随着越来越多的州将使用大麻合法化，大麻的供应量增加。 大麻市场的法规各异，产品标准不断扩大，营销限制很少， 形成了一个充满多种产品类型的市场（例如烟熏大麻、电子烟、食品、外用药） 大麻素浓度不可预测，通常超过治疗效果（THC>15%）。 产品还与急性中毒作用和长期不良反应有关。 CBD 是主要的大麻素，可能具有肝毒性，影响化疗的代谢，并导致 此外，大麻的免疫抑制作用可能会增强化学毒性。 尽管如此，患者仍会抑制免疫反应并改变免疫检查点抑制剂的功效。 普遍报告大麻可以改善癌症相关症状。目前的证据表明大麻具有临床益处。 大麻的情况好坏参半，而且往往没有结论，这主要是由于样本量和/或横截面数据较小。 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 对患者群体进行纵向研究，记录大麻使用的详细信息（即产品类型、频率、 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) 合作，该计划是一个全国网络 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 参与者将每月在线填写大麻和大麻素在治疗期间使用的益处和风险。 为期 12 个月的调查，以评估癌症相关症状和严重程度，以及详细的大麻和 这将使我们能够 (1) 描述成年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（例如恶心/ 呕吐、焦虑、神经病变）我们还将评估潜在的药代动力学和药效学影响。 通过收集和分析用于癌症治疗以及炎症和毒性标记物的变化 这些数据将有助于更好地了解肺癌患者的生物样本。 大麻和大麻素使用的异质模式与癌症症状之间的时间关系 管理；将对未来癌症治疗临床试验的设计做出重大贡献的信息。