Assessing benefits and harms of cannabis use in patients treated with immunotherapy for cancer: a prospective cohort study

评估接受癌症免疫治疗的患者使用大麻的益处和危害：一项前瞻性队列研究

• 批准号: 10792109
• 负责人: Rebecca Ashare
• 金额: $ 67.64万
• 依托单位: STATE UNIVERSITY OF NEW YORK AT BUFFALO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10792109
• 关键词: Adverse effects; Anxiety; Area; Biological; Blood Cell Count; CSF3 gene; Cancer Patient; Cancer Science; Cannabis; Clinical; Clinical Data; Cognitive; Collaborations; Computerized Medical Record; Consumption; Cross-Sectional Studies; Data; Disease; Disease Progression; Disparity; District of Columbia; Dizziness; Ecological momentary assessment; Exhibits; Fatigue; Funding; Goals; Granulocyte-Macrophage Colony-Stimulating Factor; Immune checkpoint inhibitor; Immune system; Immunologic Markers; Immunology; Immunooncology; Immunotherapy; Individual; Interdisciplinary Study; Interleukin-2; Interleukin-6; Knowledge; Legal; Link; Longitudinal Studies; Malignant Neoplasms; Measures; Medical Marijuana; Memory impairment; Mental Health; Methods; Moods; NCI-Designated Cancer Center; Oncologist; Oncology; Outcome; Pain; Patient Care; Patient Outcomes Assessments; Patients; Performance; Persons; Prevalence; Prospective, cohort study; Qualifying; Quality of life; Renal function; Reporting; Research; Role; Sampling; Schedule; Science; Severities; Site; Sleep; Sleep disturbances; Solid; Surveys; Symptoms; TNF gene; Telephone; Testing; Therapeutic; Therapeutic Uses; Time; cancer immunotherapy; cancer therapy; checkpoint therapy; cognitive task; deprivation; disparity reduction; electronic data; evidence base; health equity; immune function; immunoregulation; improved; improvement on sleep; indexing; liver function; marijuana use; marijuana use disorder; marijuana user; multidisciplinary; neighborhood disadvantage; patient safety; patient subsets; programs; progression marker; prospective; response; secondary outcome; side effect; social health determinants; substance misuse; symptom management; tumor; tumor progression; virtual

Project Abstract Up to 40% of patients report using cannabis for symptom management during and after cancer treatments despite gaps in our understanding of its longitudinal therapeutic uses and harms. Simultaneously, immuno- oncology is a rapidly advancing field of cancer treatment. Nearly 44% of cancer patients across 20 tumor types receive treatments with immunotherapy, notably Immune Checkpoint Inhibitors (ICIs), which can lead to persistent changes in the immune system for months or even years. Given cannabis also has immunomodulatory effects, there is a critical need to generate long-term data on the impact of cannabis use on longitudinal benefits and harms, immune function, and disease progression in cancer patients treated with ICIs. This proposal builds upon our existing program of research. Our team has conducted 4 NCI-funded projects regarding cannabis use in cancer patients, including 3 large cross-sectional surveys of cannabis use among patients treated at 3 NCI designated cancer centers. Across sites, 26% (n=831 of 3,169) of cancer patients reported using cannabis during treatment. However, the rate was considerably higher among patients treated with immunotherapy (32%). The overarching goal of this study is to advance the science regarding the longitudinal benefits and harms of cannabis use among those treated with ICIs for cancer. We propose a multi-site, 12-month prospective cohort study (N=450; 150 per site) with cancer patients treated with ICI (within 3 months): 225 cannabis users (regular weekly use in the prior month) and 225 cannabis non-users (no use in the past 6 months). Cannabis use, benefits, and harms will be assessed via ecological momentary assessment (collected 7 days/time point; 49 days total), patient reported outcomes will be assessed via online/phone surveys, and routine clinical data will be extracted from electronic medical records. Among a subset of 60 patients who have not yet started ICI treatment (30 cannabis users; 30 non-users), we will examine immunological markers (e.g., TNF-α, IL-6, CRP) at baseline (prior to starting ICI), 2, 6, & 12 months. The Specific Aims are to: 1) assess benefits (pain severity & interference, sleep disturbance, anxiety, quality of life) and harms (difficulty concentrating, impaired memory, dizziness, fatigue) of cannabis use over time; 2) test whether cannabis use over time moderates the associations between neighborhood disadvantage (Area Deprivation Index) and benefits and harms in Aim 1; & 3) among a subset of 60 patients with non-skin solid malignancies who have not yet started ICI, explore the association of cannabis use with disease progression and immunological markers. This timely and comprehensive study, in response to RFA-CA-22-052, will fill critical gaps in knowledge about longitudinal benefits and harms of cannabis use in persons treated with ICIs. The strong multidisciplinary team brings the requisite expertise in cancer symptom management, medical cannabis, health equity, oncology, immunology, and substance misuse. In collaboration with other funded U01s and U24, this research will have a sustained impact on the science of cancer symptom management and ultimately improve patient care and safety.

项目摘要 高达 40% 的患者报告在癌症治疗期间和治疗后使用大麻来控制症状 尽管我们对其纵向治疗用途和危害的理解存在差距，但免疫- 肿瘤学是一个快速发展的癌症治疗领域，近 44% 的癌症患者涉及 20 种肿瘤类型。 接受免疫疗法治疗，特别是免疫检查点抑制剂（ICIs），这可能会导致 免疫系统的持续变化长达数月甚至数年。鉴于大麻还具有免疫调节作用。 影响，迫切需要生成有关大麻使用对纵向效益影响的长期数据 该提案建立了接受 ICI 治疗的癌症患者的危害、免疫功能和疾病进展。 根据我们现有的研究计划，我们的团队已经开展了 4 个 NCI 资助的有关大麻使用的项目。 癌症患者，包括在 3 个 NCI 治疗的患者中进行的 3 项大型横断面调查 在各指定癌症中心，26%（3,169 名中的 831 名）癌症患者报告在治疗期间使用过大麻。 然而，接受免疫治疗的患者的这一比例要高得多（32%）。 这项研究的总体目标是推进关于纵向利弊的科学 我们提出了一个多地点、为期 12 个月的前瞻性队列研究。 研究（N=450；每个中心 150 人）接受 ICI 治疗的癌症患者（3 个月内）：225 名大麻使用者（定期 大麻的使用， 将通过生态瞬时评估（7天/时间点收集；49 总计天），患者报告的结果将通过在线/电话调查进行评估，常规临床数据将 从尚未开始 ICI 的 60 名患者的电子病历中提取。 治疗（30 名大麻使用者；30 名非使用者），我们将检查免疫标记物（例如 TNF-α、IL-6、CRP） 在基线（开始 ICI 之前）、2、6 和 12 个月时的具体目标是：1) 评估益处（疼痛严重程度）。 和干扰、睡眠障碍、焦虑、生活质量）和危害（难以集中注意力、记忆力受损、 头晕、疲劳）随着时间的推移使用大麻；2）测试随着时间的推移大麻的使用是否会缓和这种关联 邻里劣势（区域剥夺指数）与目标 1 和 3）中的利弊之间； 60 名尚未开始 ICI 的非皮肤实体恶性肿瘤患者的子集，探讨了 这项及时而全面的研究表明，大麻的使用与疾病进展和免疫学标志物有关。 对 RFA-CA-22-052 的回应，将填补有关大麻纵向利弊的知识空白 用于接受 ICI 治疗的患者 强大的多学科团队带来了癌症方面必要的专业知识。 症状管理、医用大麻、健康公平、肿瘤学、免疫学和药物滥用。 与其他资助的 U01 和 U24 合作，这项研究将对科学产生持续的影响 癌症症状管理并最终改善患者护理和安全。