Systematic Light Exposure to treat Cancer-Related Fatigue in Breast Cancer Patients

系统性光照治疗乳腺癌患者与癌症相关的疲劳

• 批准号: 9310766
• 负责人: William H Redd
• 金额: $ 73.64万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-05-17 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9310766
• 关键词: Activities of Daily Living; Address; Adjuvant; Adjuvant Chemotherapy; Adverse effects; Affect; Anthracyclines; Area; Breast Cancer Patient; Cancer Intervention; Cancer Patient; Cancer Survivor; Circadian Rhythms; Clinical; Clinical Trials; Cognition; Cognitive Therapy; Effectiveness; Exercise; Exposure to; Fatigue; Feasibility Studies; Goals; Hospitals; Hydrocortisone; Hypnosis; Intervention; Investigation; Life; Light; Malignant Neoplasms; Measures; Mediating; Medical center; Memorial Sloan-Kettering Cancer Center; Mental Depression; Moods; Neoadjuvant Therapy; New York City; Outcome; Participant; Patients; Pharmacological Treatment; Pharmacology; Pittsburgh Sleep Quality Index; Prevalence; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recommendation; Recruitment Activity; Reporting; Research; Role; Self-Administered; Site; Sleep; Sleep Disorders; Standardization; Symptoms; Testing; Time; Woman; Work; Yoga; actigraphy; active method; cancer therapy; center for epidemiological studies depression scale; chemotherapy; cost; depressive symptoms; exhaustion; experience; improved; light effects; malignant breast neoplasm; meetings; novel; patient population; prevent; public health relevance; social

PROJECT SUMMARY Cancer related fatigue (CRF) is persistent exhaustion related to cancer and/or its treatment. CRF is the most severe during treatment and can severely interfere with activities of daily living. Pharmacologic agents to treat CRF have been studied but there is insufficient evidence to recommend their use. Non- pharmacological interventions for CRF have also been studied but are costly to implement and involve significant patient burden particularly among those in active treatment. Given the clinical impact of CRF, the goal of this project is to investigate a novel low-cost/low-burden intervention: systematic light exposure (sLE) to treat CRF. Two hundred forty-eight breast cancer (BC) patients undergoing adjuvant chemotherapy will be recruited from Mount Sinai Medical Center, Roosevelt Hospital, and Memorial Sloan Kettering Cancer Center and randomized to one of two conditions: bright white light (BWL) or dim red light (DRL), a common comparison condition in light studies. The BWL intervention consists of exposure to full spectrum bright light whereas the DRL condition will involve exposure to less intense red light (< 50 lux). Both groups will self-administer 30 minutes of light from identically appearing boxes daily throughout 4 cycles of chemotherapy. Outcomes will be assessed through standardized subjective and objective measures at eight separate time points. The study will specifically address recommendations made for interventions for CRF from the NCI Clinical Trials Planning meeting (JNCI,2013).The proposed study will be the first large multisite randomized control trial (RCT) to: 1) determine if sLE affects CRF among BC patients undergoing adjuvant chemotherapy; 2) investigate whether sLE improves sleep and depressive symptoms and normalizes circadian activity and diurnal cortisol rhythms; 3) explore the possible mediational roles of sleep, circadian activity/cortisol rhythms, and depressive symptoms 4) test and intervention that can be widely and inexpensively disseminated with no harm to patients; and 5) address areas of investigation identified by the NCI as a top priority. This RCT will have major

项目总结 癌症相关性疲劳(CRF)是一种与癌症和/或其治疗相关的持续性疲惫。CRF是 在治疗过程中最严重，并可严重干扰日常生活活动。药理学 治疗慢性肾功能衰竭的药物已经研究过，但没有足够的证据推荐使用。非- 对慢性肾功能衰竭的药物干预也进行了研究，但实施和涉及的成本都很高 严重的患者负担，特别是在那些积极治疗的人中。考虑到慢性肾衰的临床影响， 本项目的目标是研究一种新的低成本/低负担的干预措施：系统光 暴露(SLE)治疗慢性肾功能衰竭。248例乳腺癌患者接受辅助治疗 化疗将从西奈山医疗中心、罗斯福医院和纪念馆招募 斯隆·凯特琳癌症中心，随机分为两种情况之一：明亮的白光(BWL)或昏暗 红灯(DRL)，光研究中常见的比较条件。BWL的干预措施包括 暴露在全光谱强光下，而DRL条件下暴露在强度较低的 红灯(&lt；50勒克斯)。这两组人将从外观相同的盒子中自行照亮30分钟 每天进行4个周期的化疗。结果将通过标准化的主观评估 并在八个不同的时间点进行客观衡量。这项研究将具体涉及 NCI临床试验规划会议对慢性肾功能衰竭干预的建议 (JNCI，2013)。拟议的研究将是第一个大型多点随机对照试验(RCT)，以：1) 确定系统性红斑狼疮是否影响接受辅助化疗的BC患者的CRF；2)调查 系统性红斑狼疮是否改善睡眠和抑郁症状，并使昼夜活动和昼夜活动正常化 皮质醇节律；3)探索睡眠、昼夜活动/皮质醇节律的可能中介作用， 和抑郁症状4)可广泛和廉价传播的测试和干预 不会对患者造成伤害；以及5)解决NCI确定为首要任务的调查领域。 这次RCT将有主要的