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.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project (R01)
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Psychosocial Risk and Disease Prevention Study Section (PRDP)
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Alfano, Catherine M
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Sloan-Kettering Institute for Cancer Research
New York
United States
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Jones, Lee W; Douglas, Pamela S; Khouri, Michel G et al. (2014) Safety and efficacy of aerobic training in patients with cancer who have heart failure: an analysis of the HF-ACTION randomized trial. J Clin Oncol 32:2496-502
Hornsby, Whitney E; Douglas, Pamela S; West, Miranda J et al. (2014) Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. Acta Oncol 53:65-74
Dolinsky, Vernon W; Rogan, Kyle J; Sung, Miranda M et al. (2013) Both aerobic exercise and resveratrol supplementation attenuate doxorubicin-induced cardiac injury in mice. Am J Physiol Endocrinol Metab 305:E243-53
Lakoski, Susan G; Barlow, Carolyn E; Koelwyn, Graeme J et al. (2013) The influence of adjuvant therapy on cardiorespiratory fitness in early-stage breast cancer seven years after diagnosis: the Cooper Center Longitudinal Study. Breast Cancer Res Treat 138:909-16
Maddocks, Matthew; Jones, Lee W; Wilcock, Andrew (2013) Immunological and hormonal effects of exercise: implications for cancer cachexia. Curr Opin Support Palliat Care 7:376-82
Jones, Lee W; Alfano, Catherine M (2013) Exercise-oncology research: past, present, and future. Acta Oncol 52:195-215
Scott, Jessica M; Lakoski, Susan; Mackey, John R et al. (2013) The potential role of aerobic exercise to modulate cardiotoxicity of molecularly targeted cancer therapeutics. Oncologist 18:221-31