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 多达40％的患者报告在癌症治疗期间和之后使用大麻进行症状管理 尽管我们了解其纵向疗法的使用和伤害方面存在差距。同时免疫 - 肿瘤学是癌症治疗的快速发展领域。在20种肿瘤类型的癌症患者中，近44％ 接受免疫疗法的治疗，特别是免疫检查点抑制剂（ICIS），这可能导致 持续变化的免疫系统数月甚至数年。鉴于大麻​​也具有免疫调节 效果，迫切需要生成有关大麻使用对纵向福利的影响的长期数据 以及用ICI治疗的癌症患者的危害，免疫功能和疾病进展。该建议建立 根据我们现有的研究计划。我们的团队已经开展了4个有关大麻使用的NCI资助的项目 在癌症患者中，包括3个NCI治疗的患者中的3项大麻使用的大型横断面调查 指定的癌症中心。在整个地点，报告了26％（3,169名）癌症患者的26％（n = 831个） 治疗。但是，在接受免疫疗法治疗的患者中，该率被认为较高（32％）。这 这项研究的总体目标是推进有关纵向利益和危害的科学 在ICI治疗的癌症治疗的人中使用大麻。我们提出了一个多站点，12个月的前瞻性队列 研究（n = 450;每个站点150个）对接受ICI治疗的癌症患者（3个月内）：225名大麻使用者（常规 在上个月每周使用）和225种大麻非用户（在过去6个月中无用）。大麻使用， 福利和危害将通过生态瞬时评估进行评估（收集7天/时间； 49 总数），将通过在线/电话调查评估患者报告的结果，常规临床数据将 从电子病历中提取。在尚未开始ICI的60名患者中的子集中 治疗（30大麻使用者； 30个非用户），我们将检查免疫标记（例如TNF-α，IL-6，CRP） 在基线（开始ICI之前），2、6和12个月。具体目的是：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，记忆力受损， 头晕，大麻的疲劳）随着时间的流逝而使用； 2）测试大麻是否随着时间的推移使用调节关联 在AIM 1中的邻里灾难（地区剥夺指数）与福利和危害之间； ＆3） 尚未开始ICI的60例非皮肤固体恶性肿瘤患者的子集，探索 大麻用于疾病进展和免疫标记。这项及时，全面的研究， 对RFA-CA-22-052的反应将填补有关大麻纵向福利和危害的关键空白 在接受ICIS处理的人使用。强大的多学科团队带来了癌症的必要专业知识 症状管理，医用大麻，健康公平，肿瘤学，免疫学和滥用药物。 与其他资助的U01和U24的合作，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。