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

Author:

Postigo-Martin Paula123,Peñafiel-Burkhardt Rafael4,Gallart-Aragón Tania5,Alcaide-Lucena Miriam5,Artacho-Cordón Francisco36,Galiano-Castillo Noelia1237,Fernández-Lao Carolina1237,Martín-Martín Lydia1237,Lozano-Lozano Mario1237,Ruíz-Vozmediano Julia8,Moreno-Gutiérrez Salvador9,Illescas-Montes Rebeca10,Arroyo-Morales Manuel1237,Cantarero-Villanueva Irene1237ORCID

Affiliation:

1. Health Sciences Faculty, University of Granada, Spain

2. Sport and Health Research Center (IMUDs), Granada, Spain

3. Institute for Biomedical Research (ibs.GRANADA), University Hospital Complex of Granada, University of Granada, Granada, Spain

4. Santa Ana General Hospital, Motril (Granada), Spain

5. Health Campus Hospital, Granada, Spain

6. Department of Radiology and Physical Medicine, University of Granada, Granada, Spain

7. Unit of Excellence on Exercise and Health (UCEES), University of Granada, Granada, Spain

8. Virgen de las Nieves Hospital, Granada, Spain

9. Department of Computer Architecture and Technology, Information and Communication Technologies Research Center (CITIC), University of Granada, Spain

10. Department of Nursing, Faculty of Health Sciences, University of Granada, Spain

Abstract

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 Tailored Therapeutic Exercise and Recovery Strategies (ATOPE) program, performed before treatment, can mitigate the onset and extent of cardiotoxicity beyond that achieved when the program is followed during treatment 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. A total of 120 women recently diagnosed with breast cancer, at risk of cardiotoxicity due to anticancer treatment awaiting surgery followed by chemotherapy and/or radiotherapy, will be randomized to either group. In a feasibility study, measurements related to recruitment rate, satisfaction with the program, adherence to them, the retention of participants, 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, and anthropometric outcomes and biological and hormonal variables will also be 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 physical therapists have an important role in this mitigation. If the ATOPE intervention performed before treatment returns better cardioprotection results, it may be recommendable that patients recently diagnosed follow this program. Impact The ATOPE program will highlight the need for a physical therapist intervention from the moment of diagnosis, in the prevention or mitigation of cardiotoxicity, in women with breast cancer. It could help physical therapists to establish an adequate therapeutic exercise dose adapted to breast cancer patients and to propose correct therapeutic exercise prescription according to the assimilation of the sessions.

Funder

Spanish Ministry of Economy and Competitiveness

Fondo de Investigación Sanitaria del Instituto de Salud Carlos

Fondos Estructurales de la Unión Europea

Spanish Ministry of Education Cultura y Deporte

Excellence Actions: Units of Excellence–Unit of Excellence on Exercise and Health

Junta de Andalucía, Consejeria de Conocimiento, Investigación y Universidades

European Regional Development Fund

Publisher

Oxford University Press (OUP)

Subject

Physical Therapy, Sports Therapy and Rehabilitation

Reference114 articles.

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2. Physical activity and sociodemographic variables related to global health, quality of life, and psychological factors in breast cancer survivors;Patsou;Psychol Res Behav Manag,2018

3. Predictors of recurrence during years 5-14 in 46,138 women with ER+ breast cancer allocated 5 years only of endocrine therapy (ET);Pan;J Clin Oncol,2016

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