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

Abstract

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.

Effect of Physical Therapy Modalities on Quality of Life of Head and Neck Cancer Survivors: A Systematic Review with Meta-Analysis

“…Research within breast and colon cancer populations has already demonstrated relevant effects of different exercise interventions on global health status, pain, QoL and fatigue through clinical trials [79][80][81][82][83][84]. Additionally, the results are coincident with other reviews on breast and colon cancer patients [28][29][30][31][32][33], considering that this intervention should be initiated as soon as possible in the early posttreatment period, even from diagnosis, as the literature increasingly supports it [25,85].…”

Cardiotoxicity of Chemotherapeutic Drugs: An Update and Future Perspectives

“…The ATOPE trial is an RCT currently recruiting patients with breast cancer and assessing whether tailored therapeutic exercise and recovery strategies can mitigate the onset and extent of cardiotoxicity (Table 3). 117…”

mHealth system (ATOPE+) to support exercise prescription in breast cancer survivors: a reliability and validity, cross-sectional observational study (ATOPE study)

“…ATOPE+ was developed by the Biomedical (BIO-277) 'CUIDATE' research group and the Department of Computer Architecture and Technology, CITIC-UGR Research Centre, both from the University of Granada, Spain. The development of ATOPE+ is part of the ATOPE project 28 , registration number NCT03787966 Clini-calTrials.gov, December 2019.…”

“…The answers were sent to the server, and the participant received an automatic personalized message about their readiness for either a high-intensity session, a moderate-intensity session, or active recovery. More information about the intervention was published on a previous protocol 28 .…”