Assessing Benefits and Harms of Medical Cannabis and Cannabinoid Use in Breast Cancer Patients During and After Treatments

评估乳腺癌患者治疗期间和治疗后医用大麻和大麻素使用的益处和危害

• 批准号: 10792287
• 负责人: Jennifer J Hu
• 金额: $ 66.36万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-20 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10792287
• 关键词: Address; Adverse effects; Adverse reactions; Aftercare; Anxiety; Biological; Biological Markers; Blood specimen; Breast Cancer Patient; Breast Cancer therapy; Cancer Center; Cancer Patient; Cannabinoids; Catchment Area; Cellular Phone; Characteristics; Clinic; Clinical; Cohort Studies; Common Terminology Criteria for Adverse Events; Country; County; Data; Decision Making; Dose; Drops; Ecological momentary assessment; Enrollment; Ensure; Environment; Florida; Frequencies; Funding; Health; Health Benefit; Immunotherapy; In complete remission; Individual; Inflammasome; Inflammation; Inflammatory; Inflammatory Response; Interdisciplinary Study; Knowledge; Longitudinal cohort; Measurement; Measures; Mediating; Medical Marijuana; Medical Technology; Minority; Monitor; Nausea; Oncologist; Outcome; Outcomes Research; Pain; Pathway interactions; Patient Outcomes Assessments; Patients; Pattern; Persons; Pharmaceutical Preparations; Physical Function; Physical activity; Physicians; Positioning Attribute; Prospective, cohort study; Quality of life; Reporting; Research; Route; Sleep; Sleep disturbances; Smoking; Source; Stable Disease; Surveys; Symptoms; Technology; Testing; Therapeutic; United States National Institutes of Health; Visit; Work; anticancer research; appetite loss; cancer therapy; cannabinoid treatment; chemotherapy; chronic pain; cognitive function; design; disorder control; dosage; emotional functioning; fitbit; high throughput technology; immunoregulation; improved; innovation; malignant breast neoplasm; multidisciplinary; new technology; novel; objective response rate; partial response; patient population; patient subsets; prevent; prospective; response; sensor; side effect; success; symptom management; symptomatic improvement; treatment planning; treatment response; tumor progression; underserved minority; vaping; wearable sensor technology

PROJECT SUMMARY/ABSTRACT Breast cancer patients represent fast-growing medical cannabis and cannabinoid (MCC) users in this country; a recent survey indicates that about 42% of breast cancer patients use MCC to alleviate treatment- related symptoms, and many of these patients do not discuss their use with their oncologists. Despite being considered safe and well-tolerated, MCC may result in potential interactions with cancer treatments, adverse reactions, and tumor progression. Unfortunately, despite the increase in MCC use, research on its health effects, including the potential benefits and harms, remains limited. Therefore, we propose a prospective cohort study of breast cancer patients (50% underserved minorities) to address gaps in knowledge and build evidence of the types of products in use, frequency, dosage of use, and the benefits and harms of MCC use during and after cancer treatment. Our central hypothesis is that MCC may improve treatment-related symptoms and clinical outcomes in some patients by targeting the inflammasome/inflammatory pathway. Therapeutic strategies targeting inflammasome may prevent treatment-related symptoms and improve clinical outcomes. We will test a new paradigm that the inhibition of inflammasome-mediated inflammatory responses by MCC plays a role in its biological effects. We plan to enroll 600 breast cancer patients (300 MCC users and 300 non-MCC users) and collect data on patient characteristics, treatment plans, clinician-reported outcomes, adverse reactions, and patient-reported outcomes. We will monitor MCC use through in-person visits and technology-based assessments such as smartphone and sensor-based measurement bursts. We will also collect blood samples for MCC quantitation/characterization and inflammasome/inflammatory biomarkers. Aim 1 will evaluate the benefits and harms of MCC in breast cancer patients during and after treatment. Aim 2 will elucidate whether inflammasome/inflammatory biomarkers mediate the benefits and harms of MCC in breast cancer therapies and other medications used. Aim 3 will investigate how MCC product characteristics impact benefits and harms (Aim 1) and inflammasome and inflammatory biomarkers (Aim 2). Leveraging our promising preliminary data, a diverse patient population, state-of-the-art high-throughput technologies, and a multidisciplinary research team with complementary expertise, we are well-positioned to conduct this study and address the scientific knowledge gaps surrounding the benefits and harms of MCC in breast cancer patients. We will provide scientific evidence on the impact of MCC on breast cancer patients during and after treatments, the biological effects of MCC during treatments, potential interactions between MCC and cancer therapies and other medications, and the types and patterns of MCC use that present the best benefits/harms ratio. Our results will be of great value to physicians and cancer patients, as they will inform decision-making regarding MCC to enhance therapies, improve quality of life, and minimize adverse effects. If funded, we will work closely with the coordinating center and NCI in sharing assessment measures and disseminating study findings.

项目概要/摘要 乳腺癌患者代表了快速增长的医用大麻和大麻素 (MCC) 使用者 国家;最近的一项调查表明，约 42% 的乳腺癌患者使用 MCC 来缓解治疗—— 相关症状，并且许多患者没有与肿瘤科医生讨论其使用情况。尽管是 MCC 被认为是安全且耐受性良好的，可能会导致与癌症治疗的潜在相互作用，不良反应 反应和肿瘤进展。不幸的是，尽管 MCC 的使用有所增加，但对其健康影响的研究， 包括潜在的好处和危害，仍然有限。因此，我们提出一项前瞻性队列研究 的乳腺癌患者（50% 服务不足的少数族裔），以解决知识差距并建立证据 使用的产品种类、使用频率、用量以及使用MCC期间和之后的利弊 癌症治疗。我们的中心假设是 MCC 可以改善治疗相关症状和临床症状 通过靶向炎症小体/炎症途径来治疗某些患者的结果。治疗策略 针对炎症体可以预防治疗相关症状并改善临床结果。我们将测试一个 MCC 抑制炎症小体介导的炎症反应在其发挥作用的新范式 生物效应。我们计划招募 600 名乳腺癌患者（300 名 MCC 用户和 300 名非 MCC 用户） 收集有关患者特征、治疗计划、临床医生报告的结果、不良反应和 患者报告的结果。我们将通过亲自访问和基于技术的方式监控 MCC 的使用情况 评估，例如智能手机和基于传感器的测量突发。我们还将采集血液样本 用于 MCC 定量/表征和炎症小体/炎症生物标志物。目标 1 将评估 MCC 对乳腺癌患者治疗期间和治疗后的益处和危害。目标 2 将阐明是否 炎症小体/炎症生物标志物介导 MCC 在乳腺癌治疗中的益处和危害 使用的其他药物。目标 3 将调查 MCC 产品特性如何影响效益和危害（Aim 1) 以及炎症小体和炎症生物标志物（目标 2）。利用我们有希望的初步数据， 多样化的患者群体、最先进的高通量技术和多学科研究团队 凭借互补的专业知识，我们有能力开展这项研究并解决科学问题 关于 MCC 对乳腺癌患者的益处和危害的知识差距。我们将提供科学的 MCC 对乳腺癌患者在治疗期间和治疗后的影响的证据， 治疗期间的 MCC、MCC 与癌症治疗和其他药物之间的潜在相互作用，以及 呈现最佳效益/危害比的 MCC 使用类型和模式。我们的成果将具有巨大的价值 向医生和癌症患者提供信息，因为他们将为有关 MCC 的决策提供信息，以增强治疗效果， 提高生活质量，尽量减少不良影响。如果获得资助，我们将与协调中心密切合作 和 NCI 分享评估措施并传播研究结果。