Sports Cardiology Lab, Clinical Research Domain, Baker Heart and Diabetes Institute, 75 Commercial Rd, Melbourne, VIC, 3004, Australia.
Institute of Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC, Australia.
BMC Cancer. 2020 Jul 14;20(1):655. doi: 10.1186/s12885-020-07123-6.
Anthracycline chemotherapy (AC) is an efficacious (neo) adjuvant treatment for early-stage breast cancer (BCa), but is associated with an increased risk of cardiac dysfunction and functional disability. Observations suggest that regular exercise may be a useful therapy for the prevention of cardiovascular morbidity but it is yet to be interrogated in a large randomised trial. The primary aims of this study are to: 1) determine if 12-months of ET commenced at the onset of AC can reduce the proportion of BCa patients with functional disability (peak VO, < 18 ml/kg/min), and 2) compare current standard-of-care for detecting cardiac dysfunction (resting left-ventricular ejection fraction assessed from 3-dimensional echocardiography) to measures of cardiac reserve (peak exercise cardiac output assessed from exercise cardiac magnetic resonance imaging) for predicting the development of functional disability 12-months following AC. Secondary aims are to assess the effects of ET on VO2peak, left ventricular morphology, vascular stiffness, cardiac biomarkers, body composition, bone mineral density, muscle strength, physical function, habitual physical activity, cognitive function, and multidimensional quality of life.
One hundred women with early-stage BCa (40-75 years) scheduled for AC will be randomized to 12-months of structured exercise training (n = 50) or a usual care control group (n = 50). Participants will be assessed at baseline, 4-weeks following completion of AC (4-months) and at 12-months for all measures.
Women diagnosed with early-stage BCa have increased cardiac mortality. More sensitive strategies for diagnosing and preventing AC-induced cardiovascular impairment are critical for reducing cardiovascular morbidity and improving long-term health outcomes in BCa survivors.
Australia & New Zealand Clinical Trials Registry (ANZCTR), ID: 12617001408370 . Registered on 5th of October 2017.
蒽环类化疗（AC）是早期乳腺癌（BCa）有效（新）辅助治疗方法，但与心脏功能障碍和功能障碍风险增加相关。观察表明，定期运动可能是预防心血管发病率的有用治疗方法，但尚未在大型随机试验中进行探讨。本研究的主要目的是：1）确定在开始 AC 时开始的 12 个月 ET 是否可以降低 BCa 患者功能障碍（峰值 VO，<18 ml/kg/min）的比例，2）比较目前用于检测心脏功能障碍（从 3 维超声心动图评估静息左心室射血分数）的标准与评估心脏储备的指标（从运动心脏磁共振成像评估峰值运动心输出量）用于预测 AC 后 12 个月功能障碍的发展。次要目标是评估 ET 对 VO2peak、左心室形态、血管僵硬、心脏生物标志物、身体成分、骨密度、肌肉力量、身体功能、习惯性体力活动、认知功能和多维生活质量的影响。
将 100 名计划接受 AC 的早期 BCa 女性（40-75 岁）随机分为 12 个月的结构化运动训练组（n=50）或常规护理对照组（n=50）。参与者将在基线、AC 完成后 4 周（4 个月）和 12 个月进行所有测量。
诊断为早期 BCa 的女性心脏死亡率增加。更敏感的诊断和预防 AC 诱导的心血管损伤的策略对于降低心血管发病率和改善 BCa 幸存者的长期健康结果至关重要。
澳大利亚和新西兰临床试验注册中心（ANZCTR），ID：12617001408370。于 2017 年 10 月 5 日注册。
