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.

项目总结/摘要 乳腺癌患者代表了快速增长的医用大麻和大麻素（MCC）用户， 最近的一项调查表明，大约42%的乳腺癌患者使用MCC来减轻治疗- 这些患者中的许多人没有与他们的肿瘤学家讨论他们的使用。尽管是 MCC被认为是安全和耐受性良好的，可能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的使用增加，但对其健康影响的研究， 包括潜在的利益和危害，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%的服务不足的少数民族），以解决知识的差距，并建立证据， 使用中的产品类型、频率、使用剂量以及MCC使用期间和之后的益处和危害 癌症治疗我们的中心假设是MCC可能改善治疗相关症状和临床表现。 通过靶向炎性体/炎症途径，在一些患者中获得了良好的结果。治疗策略 靶向炎性小体可以预防治疗相关症状并改善临床结果。我们将测试 MCC抑制炎性小体介导的炎症反应在其治疗中发挥作用的新范式 生物效应。我们计划招募600名乳腺癌患者（300名MCC使用者和300名非MCC使用者）， 收集有关患者特征、治疗计划、临床医生报告的结局、不良反应的数据，以及 患者报告的结局。我们将通过亲自访问和基于技术的 评估，如智能手机和基于传感器的测量突发。我们还将收集血液样本 用于MCC定量/表征和炎性体/炎性生物标志物。目标1将评估 MCC在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 炎症体/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将研究MCC产品特性如何影响受益和危害（目标 1)以及炎性小体和炎性生物标志物（Aim 2）。利用我们的初步数据， 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，我们有能力进行这项研究，并解决科学问题。 围绕MCC在乳腺癌患者中的益处和危害的知识差距。我们将提供科学的 MCC在治疗期间和治疗后对乳腺癌患者影响的证据， 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 MCC使用的类型和模式呈现出最佳的获益/危害比。我们的研究结果将具有很大的价值 医生和癌症患者，因为他们将告知有关MCC的决策，以加强治疗， 提高生活质量，并将不良影响降至最低。如果获得资助，我们将与协调中心密切合作 和国家癌症研究所分享评估措施和传播研究结果。