Aerobic Training During or After Adjuvant Therapy: A Randomized Trial

描述（由申请人提供）：运动训练是乳腺癌患者在完成主要治疗（即，化疗和放疗）。相比之下，运动在原发性BC治疗中的作用不太被接受。事实上，存在这样一种看法，即由于依从性差和损耗率低、不良事件风险升高和患者选择偏倚显著，在治疗期间可能无法进行科学严格的运动试验。然而，越来越多的研究表明，运动是一种有效的治疗，以减轻某些癌症相关的毒性（例如， 失调、疲劳），依从性和损耗率均在常规可接受的水平内，AE极少。尽管在过去的十年里，在治疗期间接受锻炼已经取得了重大进展，但普遍的教条仍然是在初级治疗期间应避免锻炼。我们提出了一项四臂随机对照试验，以比较在运动期间、运动之后或运动期间和运动之后（即，连续AT）标准初级治疗，相对于注意力控制，在160例（n=40/组）早期BC患者。这项赠款的目标如下：（1）比较治疗期间有氧训练和对照组与治疗后有氧训练和对照组之间的心肺适能差异，（2）比较控制有氧训练-适能关系的氧运输器官的差异，以及（3）比较患者报告的结局、不良事件、依从性、和研究组之间的损耗率。次要目的是比较连续有氧训练相对于所有其他组对主要目的1 - 3的影响。 公共卫生相关性：在过去的十年里，在诊断出早期乳腺癌后，对运动应用的临床和研究兴趣急剧增加。尽管有越来越多的证据基础，肿瘤学专业人员和患者仍然对主要治疗期间有氧训练的安全性，耐受性和有效性持怀疑态度。然而，在治疗期间避免运动可能会产生毁灭性的急性和迟发性后果。有强烈的需要，以确定最佳的时机，其中启动AT，最大限度地提高安全性和耐受性的运动，同时产生最有利的改善心肺功能和其他相关的结果后，诊断早期乳腺癌。本项目将比较有氧训练期间、之后或期间和之后（即，连续有氧训练）标准初级治疗，相对t对照，在160例（n=40/组）早期乳腺癌患者中。

DESCRIPTION (provided by applicant): Exercise training is a safe and efficacious intervention for breast cancer patients following the completion of primary therapy (i.e., chemotherapy and radiation). In contrast, the role of exercise during primary BC therapy is less well accepted. Indeed, a perception exists that the conduct of scientifically rigorous exercise trials may not be possible during therapy due to poor adherence and attrition rates, elevated risk of adverse events, and significant patient selection bias. Nevertheless, a growing number of studies indicate that exercise is an effective therapy to mitigate certain cancer-related toxicities (e.g., deconditioning, fatigue) with adherence and attrition rates well within conventionally accepted levels, and with minimal AEs. Although the acceptance of exercise during therapy has made significant strides over the past decade, the prevailing dogma is still that exercise should be avoided during primary therapy. We propose a four-arm RCT to compare the effects and safety of supervised aerobic training performed during, after, or during and after (i.e., continuous AT) standard primary therapy, relative to attention-control, in 160 (n=40/group) early-stage BC patients. This grant has the following objectives: Primary aims: (1) To compare the difference in cardiorespiratory fitness between aerobic training and control during therapy versus aerobic training and control after therapy, (2) To compare the difference in oxygen transport organs that govern the aerobic training - fitness relationship, and (3) to compare the difference in patient-reported outcomes, adverse events, adherence, and attrition rates between study groups. A secondary aim is to compare the effect of continuous aerobic training, relative to all other groups, on primary aims 1 - 3. PUBLIC HEALTH RELEVANCE: The past decade has witnessed a dramatic increase in clinical and research interest in the application of exercise following a diagnosis of early breast cancer. Despite the growing evidence base, oncology professionals and patients remain skeptical of the safety, tolerability, and efficacy of aerobic training during primary therapy. Avoiding exercise during therapy may, however, have devastating acute as well as late- occurring consequences. There is a strong need to identify the optimal timing in which to initiate AT that maximizes the safety and tolerability of exercise whilst producing the most favorable improvements in cardiorespiratory fitness and other pertinent outcomes following a diagnosis of early breast cancer. This project will compare the effects and safety of aerobic training performed during, after, or during and after (i.e., continuous aerobic training) standard primary therapy, relative t control, in 160 (n=40/group) early-stage breast cancer patients.