Aerobic Training During or After Adjuvant Therapy: A Randomized Trial

描述(申请人提供)：运动训练是乳癌患者在完成初步治疗(即化疗和放射治疗)后的安全和有效的干预措施。相比之下，运动在初级BC治疗中的作用不太被接受。事实上，存在一种看法，即在治疗期间进行科学严格的运动试验可能是不可能的，因为依从性和流失率较低，不良事件的风险增加，以及严重的患者选择偏差。然而，越来越多的研究表明，锻炼是减轻某些癌症相关毒性的有效疗法(例如， 解除条件、疲劳)，粘附率和磨损率都在常规可接受的水平内，且不良反应最小。尽管在过去的十年里，在治疗期间接受锻炼已经取得了很大的进步，但流行的教条仍然是，在初级治疗期间应该避免锻炼。我们提出了一个四臂RCT来比较160例(n=40/组)早期BC患者在标准初级治疗(即持续AT)期间、之后、期间和之后进行的有监督有氧训练相对于注意力控制的效果和安全性。这笔赠款有以下目标：(1)比较治疗期间有氧训练和控制与治疗后有氧训练和控制之间的心肺健康差异；(2)比较控制有氧训练和健康关系的氧气运输器官的差异；(3)比较患者报告的结果、不良事件、依从性和流失率的差异。第二个目标是比较持续有氧训练相对于所有其他组在主要目标1-3上的效果。

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.