Colditz Hannes, Matits Lynn, Kersten Johannes, Schulz Sebastian Viktor Waldemar, Buckert Dominik, Beer Meinrad, Janni Wolfgang, Kersten Maria, Klömpken Steffen, Fink Visnja, Leinert Elena, Bizjak Daniel Alexander, Schellenberg Jana
Sports and Rehabilitation Medicine, Ulm University Hospital, Ulm, Baden-Württemberg, Germany.
Clinical and Biological Psychology, Institute of Psychology and Education, Ulm University, Ulm, Baden-Württemberg, Germany.
BMJ Open Sport Exerc Med. 2024 Nov 2;10(4):e002265. doi: 10.1136/bmjsem-2024-002265. eCollection 2024.
The incidence of breast cancer has increased from 900 000 to 2.3 million new annual cases over the last 25 years. The 5-year survival rate has markedly risen to over 90% worldwide due to significant therapeutic advancements. Longer survival in patients with breast cancer means more patients may experience long-term effects of their treatments, including cancer therapy-related cardiac dysfunction (CTRCD). To date, there is no established primary prevention to minimise CTRCD. The Cardiac Health in Breast Cancer study is a two-arm, single-centre, randomised controlled trial investigating the impact of an exercise programme on cardiac changes in patients with breast cancer undergoing cardiotoxic cancer therapy. 48 females with breast cancer will be randomised to either a 12-month intervention group (IG) or a control group (CG). The IG will receive a combination of supervised high-intensity interval training (HIIT) and high-intensity resistance training (HIRT) for 6 months, while the CG will follow WHO guidelines for physical activity independently. All participants will undergo transthoracic echocardiography, cardiac magnetic resonance (CMR) imaging and cardiopulmonary exercise testing at baseline, after 6 months and after 12 months. The primary endpoint is the occurrence of symptomatic or asymptomatic CTRCD at the time points of examination, detected by cardiac imaging, which may be mitigated by structured physical exercise. Secondary endpoints include assessments of cardiac inflammation as detected by CMR, mitochondrial dysfunction, health-related quality of life, the occurrence of fatigue, depression and anxiety, as well as exercise capacity, average heart rate, heart rate variability and daily physical activity.
在过去25年中，乳腺癌的年新增病例数已从90万增至230万。由于治疗方面的显著进步，全球乳腺癌患者的5年生存率已显著提高至90%以上。乳腺癌患者生存期延长意味着更多患者可能会经历治疗的长期影响，包括癌症治疗相关的心脏功能障碍（CTRCD）。迄今为止，尚无既定的一级预防措施可将CTRCD降至最低。乳腺癌心脏健康研究是一项双臂、单中心随机对照试验，旨在研究运动计划对接受心脏毒性癌症治疗的乳腺癌患者心脏变化的影响。48名乳腺癌女性患者将被随机分为12个月的干预组（IG）或对照组（CG）。干预组将接受为期6个月的有监督的高强度间歇训练（HIIT）和高强度抗阻训练（HIRT），而对照组将独立遵循世界卫生组织的身体活动指南。所有参与者将在基线、6个月后和12个月后接受经胸超声心动图、心脏磁共振（CMR）成像和心肺运动测试。主要终点是在检查时间点通过心脏成像检测到的有症状或无症状的CTRCD的发生情况，结构化体育锻炼可能会减轻这种情况。次要终点包括通过CMR检测到的心脏炎症、线粒体功能障碍、健康相关生活质量、疲劳、抑郁和焦虑的发生情况，以及运动能力、平均心率、心率变异性和日常身体活动。
