Attenuating Treatment-Related Cardiotoxicity in Women Recently Diagnosed with Breast Cancer via a Tailored Therapeutic Exercise Program: Protocol of the ATOPE Trial.

OBJECTIVE Therapeutic exercise is already used to ameliorate some of the side effects of cancer treatment. Recent studies examined its preventive potential regarding treatment-related toxicity, which can increase the risk of functional decline and lead to disease recurrence and death. This trial will examine whether the ATOPE (Tailored Therapeutic Exercise and Recovery Strategies) program, performed before treatment (ATOPE-B), can mitigate the onset and extent of cardiotoxicity beyond that achieved when the program is followed during treatment (ATOPE-I) in recently diagnosed breast cancer patients. METHODS The intervention has a preparatory phase plus 12 to 18 sessions of tailored, high-intensity exercise, and post-exercise recovery strategies. 120 women recently diagnosed with breast cancer, in risk of cardiotoxicity due to anticancer treatment awaiting surgery followed by chemotherapy and/or radiotherapy, will be randomised to either group. In a feasibility study, measurements related to recruitment rate, satisfaction with the program, adherence to them, the retention of subjects, safety, and adverse effects will be explored. In the main trial, the efficacy of these interventions will be examined. The major outcome will be cardiotoxicity, assessed echocardiographically via the left ventricular ejection fraction. Other clinical, physical, anthropometric outcomes, biological and hormonal variables, will be also assessed after diagnosis, after treatment, 1 year after treatment ends, and 3 years after treatment ends. CONCLUSION Given its potential effect on patient survival, the mitigation of cardiotoxicity is a priority, and physiotherapists have an important role in this mitigation. If the ATOPE-B intervention returns better cardioprotection results, it may be recommendable that patients recently diagnosed follow this program.