Randomized Phase II Trial of Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women with Hormone Receptor Positive Advanced Breast Cancer (FastER)

长期隔夜禁食和/或运动对激素受体阳性晚期乳腺癌女性患者疲劳和其他患者报告结果的随机 II 期试验 (FastER)

• 批准号: 10714371
• 负责人: Tracy E Crane
• 金额: $ 81.06万
• 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/10714371
• 关键词: Address; Advanced Malignant Neoplasm; Adverse effects; Anxiety; Aromatase Inhibitors; Attenuated; Biological Markers; Body Composition; C-reactive protein; CDK4 gene; Carbohydrates; Chemotherapy and/or radiation; Circadian Rhythms; Cyclin-Dependent Kinase Inhibitor; Data; Development; Diet; Dietary Intervention; Dose; Eating; Effectiveness; Enrollment; Evaluation; Exercise; Fasting; Fatigue; Fulvestrant; Goals; Hormone Receptor; Hour; Individual; Inflammation; Inflammatory; Interleukin-6; Intermittent fasting; Intervention; Life; Mediating; Menopausal Symptom; Mental Depression; Metastatic breast cancer; Minority Groups; Mood Disorders; Neutropenia; Outcome; Outcome Study; Participant; Patient Outcomes Assessments; Patients; Pharmaceutical Preparations; Phase; Physical Function; Physical activity; Physical assessment; Pilot Projects; Population; Quality of life; Randomized; Randomized, Controlled Trials; Reporting; Research; Risk; Sampling; Sleep; Sleep disturbances; TNF gene; Testing; Toxic effect; Treatment Side Effects; Treatment-related toxicity; Underrepresented Minority; Well in self; Woman; acceptability and feasibility; advanced breast cancer; advanced disease; adverse outcome; attentional control; cancer initiation; cancer therapy; chemotherapy; circadian; diet and exercise; ethnic diversity; exercise intensity; exercise intervention; exercise training; experience; feasibility testing; gastrointestinal; hormone receptor-positive; hormone therapy; improved; improved outcome; improvement on sleep; inflammatory marker; inhibitor; inhibitor therapy; intervention effect; lifestyle intervention; malignant breast neoplasm; novel; patient population; phase II trial; post intervention; preservation; primary outcome; psychologic; secondary outcome; side effect; targeted treatment; tumor

Abstract More than 40,000 women die each year of metastatic breast cancer. The majority of these tumors are hormone receptor positive (HR+) that are treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor in combination with an aromatase inhibitor or fulvestrant. With these treatments, women with advanced breast cancer are living longer, but treatment related toxicities inevitably occur, and quality of life is limited by side effects of cancer treatment which may result in dose reductions and delays. Fatigue is the most commonly cited adverse side effect reported for women taking CDK4/6 inhibitors and mechanistically may be associated with inflammation. When unmanaged, fatigue is debilitating directly impacting both psychological and physical quality of life and a key driver in discontinuation of therapy. Lifestyle interventions targeting diet and exercise have evidence for improving fatigue in early stage breast cancer, however whether these strategies are efficacious for improving outcomes in women with advanced breast cancer remains unknown, with even less information for women from underrepresented backgrounds, who suffer disproportionately from breast cancer and its treatment. Research regarding the impact of these strategies on high grade fatigue induced by CDK4/6 inhibitors in advanced disease from a diverse patient population are needed. The prolonged overnight Fasting and/or Exercise on fatigue and other patient reported outcomes in women with hormone Receptor positive advanced breast cancer (FastER) study, will evaluate a phase II, 2 x 2 randomized controlled trial testing the effects of a prolonged overnight fasting (POF) intervention alone, moderate-intensity exercise alone, or in combination, on fatigue in 260 women with advanced breast cancer initiating treatment with hormonal therapy in combination with a CDK4/6 inhibitor. Participants would undergo assessment of fatigue and associated inflammatory biomarkers, as well as assessment of physical activity, diet, physical function, body composition and patient reported outcomes at baseline (prior to the initiation of CDK4/6 inhibitor) and 12 weeks (post-intervention), 6 and 12 months after study enrollment. The primary outcome of the study is to evaluate the impact of the interventions (vs control) on fatigue in women at 12 weeks. Secondary outcomes include inflammatory biomarkers, patient-reported outcomes, physical function and body composition. The FastER study will also explore the impact of the intervention on circadian rhythms, fatigue, sleep, depression, anxiety, quality of life, physical function and body composition. The overarching goal of the FastER study is to determine whether prolonged overnight fasting or moderate- intensity exercise alone or in combination can mitigate the adverse consequences of treatment and improve fatigue and other outcomes, in women with advanced breast cancer treated with CDK4/6 inhibitors to ultimately improve both quantity and quality of life for this growing population of women.

抽象的 每年有40,000多名妇女死于转移性乳腺癌。这些肿瘤中的大多数是激素 组合用细胞周期蛋白依赖激酶4/6（CDK4/6）抑制剂处理的受体阳性（HR+）组合处理 与芳香酶抑制剂或燃烧室。通过这些治疗，患有晚期乳腺癌的女性是 寿命更长，但不可避免地会发生与治疗相关的毒性，生活质量受到 癌症治疗可能导致剂量减少和延迟。疲劳是最常见的不利 报道了服用CDK4/6抑制剂的妇女的副作用，机理上可能与 炎。当不受管理时，疲劳正在使人虚弱直接影响心理和身体 生活质量和停用治疗的主要驱动力。针对饮食和运动的生活方式干预措施 有证据可以改善早期乳腺癌的疲劳，但是这些策略是否是 改善晚期乳腺癌女性预后的有效性仍然未知，甚至更少 来自代表性不足的妇女的信息，她们因乳腺癌而遭受不成比例的痛苦 及其处理。有关这些策略对CDK4/6引起的高级疲劳的影响的研究 需要来自多样化患者人群的晚期疾病的抑制剂。 长时间的夜间禁食和/或运动疲劳和其他患者报告 激素受体阳性晚期乳腺癌（更快）研究的女性结果，将 评估II期2 x 2随机对照试验测试延长过夜禁食（POF）的影响 仅干预，单独进行中等强度运动或组合在260名患有疲劳的疲劳 晚期乳腺癌与CDK4/6抑制剂结合使用激素治疗开始治疗。 参与者将接受疲劳和相关炎症生物标志物的评估，以及 评估体育锻炼，饮食，身体功能，身体成分和患者报告的预后 基线（在启动CDK4/6抑制剂之前）和12周（干预后），6和12个月后 研究入学。该研究的主要结果是评估干预措施的影响（VS控制） 关于女性在12周时的疲劳。次要结果包括炎症生物标志物，患者报告 结果，身体功能和身体成分。更快的研究还将探讨 干预昼夜节律，疲劳，睡眠，抑郁，焦虑，生活质量，身体功能和身体 作品。 更快的研究的总体目标是确定长时间的禁食或中等目标是 单独或组合使用强度运动可以减轻治疗的不利后果并改善 疲劳和其他结果，在接受CDK4/6抑制剂治疗的晚期乳腺癌的女性中 改善不断增长的妇女人群的生活数量和质量。