Martha A. Cancilla, Donya Nemati, Danielle Halsey, Niraj Shah, Melissa Sherman, Nicholas Kelly, Pengyue Zhang, Nada Kassem, Navin Kaushal, Kelly Shanahan, Lesley Kailani Glenn, Jennifer A. Ligibel, Tarah J. Ballinger
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The EMBody trial aims to determine the impact of a multimodal exercise intervention on cardiorespiratory fitness, physical function, body composition, and patient-reported outcomes, specifically in patients with stable, indolent MBC. Eligible patients have MBC with no evidence of disease progression on current therapy in the prior 12 months and cannot be receiving cytotoxic chemotherapy. The trial aims to enroll 100 patients, randomized 1:1 to the exercise intervention versus usual care, stratified by baseline function. The virtually-delivered exercise intervention arm achieves moderate intensity exercise with exercise physiologists 3 days/week for 16 weeks. The 60-minute sessions include aerobic, resistance, balance and stretching exercises. The exercise arm receives informational sessions on the role of exercise in cancer and principles of habit and self-efficacy. The primary endpoint is 16 week change in fitness on a ramp treadmill test between the exercise and control arms. Secondary endpoints include change in a physical function, muscle mass assessed by CT scans, and PROs of fatigue and quality of life. Exploratory analysis includes behavioral modifiers of exercise adherence and effectiveness and serologic measures of inflammatory, metabolic, and immune pathway biomarkers. The EMBody trial evaluates exercise in a unique patient population with indolent, non-progressive MBC. Patients living with MBC experience similar symptom burden to those undergoing therapy for early-stage disease and the benefits achieved with exercise could be similarly impactful. This trial will contribute evidence to support expansion of exercise recommendations, among other survivorship care efforts, to those living with metastatic disease. Clinical trial information: NCT05468034. NCT05468034. 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引用次数: 0
摘要
在早期乳腺癌患者中,运动与生存期、身体机能、治疗耐受性和生活质量的改善有关。这些终点对转移性乳腺癌(MBC)同样重要。之前对 MBC 进行的试验发现,运动并不可行或获益有限,这可能是由于纳入了不同疾病轨迹的患者。MBC患者的疾病轨迹和支持性护理需求各不相同;而惰性MBC患者的预期寿命较长、症状负担较轻且有不同的优先考虑事项,他们完全有能力参与锻炼计划并从中获益。EMBody 试验旨在确定多模式运动干预对心肺功能、身体机能、身体成分和患者报告结果的影响,特别是对病情稳定、不活跃的 MBC 患者的影响。符合条件的 MBC 患者在过去 12 个月内接受当前治疗后无疾病进展迹象,且不能接受细胞毒性化疗。该试验的目标是招募 100 名患者,按基线功能分层,以 1:1 随机分配给运动干预与常规护理。虚拟运动干预组在运动生理学家的指导下进行中等强度的运动,每周 3 天,共 16 周。60 分钟的课程包括有氧、阻力、平衡和伸展运动。运动干预组将接受关于运动在癌症中的作用以及习惯和自我效能原则的信息讲座。主要终点是运动组和对照组在斜坡跑步机测试中 16 周的体能变化。次要终点包括身体机能的变化、CT 扫描评估的肌肉质量以及疲劳和生活质量的主要指标。探索性分析包括运动依从性和有效性的行为调节因素,以及炎症、代谢和免疫途径生物标记物的血清学测量。EMBody 试验评估的是一个独特的患者群体,他们都是非进展性、轻度 MBC 患者。MBC 患者的症状负担与接受早期疾病治疗的患者相似,而通过锻炼获得的益处可能会产生类似的影响。这项试验将为支持将运动建议和其他幸存者护理工作扩展到转移性疾病患者提供证据。临床试验信息:NCT05468034。NCT05468034。注册日期:7/12/2022.
Exercise as part of survivorship care in metastatic breast cancer: protocol for the randomized EMBody trial
Exercise is associated with improved survival, physical functioning, treatment tolerability, and quality of life in early-stage breast cancer. These same endpoints matter in metastatic breast cancer (MBC). Prior trials in MBC have found exercise to be not feasible or of limited benefit, possibly due to inclusion of patients with heterogeneous disease trajectories. Patients with MBC have variable disease trajectories and supportive care needs; those with indolent MBC have longer life expectancy, lower symptom burden and distinct priorities, and are well-positioned to participate in and benefit from an exercise program. The EMBody trial aims to determine the impact of a multimodal exercise intervention on cardiorespiratory fitness, physical function, body composition, and patient-reported outcomes, specifically in patients with stable, indolent MBC. Eligible patients have MBC with no evidence of disease progression on current therapy in the prior 12 months and cannot be receiving cytotoxic chemotherapy. The trial aims to enroll 100 patients, randomized 1:1 to the exercise intervention versus usual care, stratified by baseline function. The virtually-delivered exercise intervention arm achieves moderate intensity exercise with exercise physiologists 3 days/week for 16 weeks. The 60-minute sessions include aerobic, resistance, balance and stretching exercises. The exercise arm receives informational sessions on the role of exercise in cancer and principles of habit and self-efficacy. The primary endpoint is 16 week change in fitness on a ramp treadmill test between the exercise and control arms. Secondary endpoints include change in a physical function, muscle mass assessed by CT scans, and PROs of fatigue and quality of life. Exploratory analysis includes behavioral modifiers of exercise adherence and effectiveness and serologic measures of inflammatory, metabolic, and immune pathway biomarkers. The EMBody trial evaluates exercise in a unique patient population with indolent, non-progressive MBC. Patients living with MBC experience similar symptom burden to those undergoing therapy for early-stage disease and the benefits achieved with exercise could be similarly impactful. This trial will contribute evidence to support expansion of exercise recommendations, among other survivorship care efforts, to those living with metastatic disease. Clinical trial information: NCT05468034. NCT05468034. Date of registration: 7/12/2022.
期刊介绍:
BMC Cancer is an open access, peer-reviewed journal that considers articles on all aspects of cancer research, including the pathophysiology, prevention, diagnosis and treatment of cancers. The journal welcomes submissions concerning molecular and cellular biology, genetics, epidemiology, and clinical trials.