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ATOPE-PRO
ATOPE-PRO: Effects on the Prevention of Breast Cancer Therapy-related Cardiovascular Toxicity of a Daily-adapted and Individualized Program With Support From a Mobile Application
Sponsor study identifier
interventional
102
1 country
1
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
ATOPE-PRO, was developed with the intention of consolidating the integration of an innovative system for the prevention of cancer therapy-related cardiovascular toxicity (CTR-CVT) in the continuum care of women with breast cancer in health services. It is a step further towards personalized medicine by optimizing the already available tools and integrating artificial intelligence. Breast cancer survival increases every year, a situation that poses new challenges for health professionals. The European Society for Medical Oncology, a reference in Europe, has just highlighted the need to anticipate to and prevent sequelae derived from the disease and its treatments. This, in addition to having a positive impact on improving the quality of life of people suffering from this disease, would mean a reduction in the risk of recurrence, the appearance of other tumors and other diseases, and death from cancer or other causes, which have a personal impact and represent an overload of the healthcare system. To this end, ATOPE- PRO aims to optimize and refine tools already developed in the previous project (ATOPE, Pl18/01840), integrating artificial intelligence to help identify CTR-CVT, risk profiles, and effective and safe doses (at a clinical level) early on, implementing the program in a longer term, and transferring the results to the social sector (social level). The project has 4 stages: Phase 0 or start-up (to make improvements and analyse usability); Phase 1 for piloting and optimization; Phase 2, to verify efficacy (randomized controlled clinical trial) and Phase 3, in which a deep analysis will be performed and future projects will be conceived.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 11, 2024
Actual (reported)July 24, 2024
Actual (reported)September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Cardiotoxicity
Echocardiography: left ventricular ejection fraction expressed as percentage.
At diagnosis before treatments, after 6 months, and one year after diagnosis.
Systolic function
Echocardiography: Strain longitudinal global expressed as percentage.
At diagnosis before treatments, after 6 months, and one year after diagnosis.
Number of cardiovascular events
At diagnosis before treatments, after 6 months, and one year after diagnosis.
Comorbidities
At diagnosis before treatments, after 6 months, and one year after diagnosis.
Heart rate variability
At diagnosis before treatments, after 6 months, and one year after diagnosis.
Heart rate
At diagnosis before treatments, after 6 months, and one year after diagnosis.
Blood pressure
At diagnosis before treatments, after 6 months, and one year after diagnosis.
Health recommendations (educational videos) + Individualised exercise intervention
Health recommendations (educational videos)
Individualised recommendations for physical activity and exercise, lifestyle, stress management and symptom management with solid scientific evidence established by health organisations and scientific reference committeess through the ATOPE-PRO mobile application based on patients reported status.
Recommendations for physical activity and exercise, lifestyle, stress management and symptom management with solid scientific evidence established by health organisations and scientific reference committeess through the ATOPE-PRO mobile application.
University of Granada
Granada, 18016, Spain
Postigo-Martin P, Penafiel-Burkhardt R, Gallart-Aragon T, Alcaide-Lucena M, Artacho-Cordon F, Galiano-Castillo N, Fernandez-Lao C, Martin-Martin L, Lozano-Lozano M, Ruiz-Vozmediano J, Moreno-Gutierrez S, Illescas-Montes R, Arroyo-Morales M, Cantarero-Villanueva I. Attenuating Treatment-Related Cardiotoxicity in Women Recently Diagnosed With Breast Cancer via a Tailored Therapeutic Exercise Program: Protocol of the ATOPE Trial. Phys Ther. 2021 Mar 3;101(3):pzab014. doi: 10.1093/ptj/pzab014.
Gonzalez-Santos A, Postigo-Martin P, Gallart-Aragon T, Esteban-Cornejo I, Lopez-Garzon M, Galiano-Castillo N, Arroyo-Morales M, Illescas-Montes R, Artacho-Cordon F, Martin-Martin L, Forneiro-Perez R, Lozano-Lozano M, Fernandez-Lao C, Ruiz-Vozmediano J, Sanchez-Salgado C, Cantarero-Villanueva I. Neurotoxicity prevention with a multimodal program (ATENTO) prior to cancer treatment versus throughout cancer treatment in women newly diagnosed for breast cancer: Protocol for a randomized clinical trial. Res Nurs Health. 2021 Aug;44(4):598-607. doi: 10.1002/nur.22136. Epub 2021 May 7.
Irene Cantarero Villanueva, PhD
Universidad de Granada
First Submitted
July 11, 2024
First Posted
July 24, 2024
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Follow-up of an individualised exercise program adjusted by daily monitoring of the level of physical, physiological and psychological condition.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Postigo-Martin P, Gil-Gutierrez R, Moreno-Gutierrez S, Lopez-Garzon M, Gonzalez-Santos A, Arroyo-Morales M, Cantarero-Villanueva I. mHealth system (ATOPE+) to support exercise prescription in breast cancer survivors: a reliability and validity, cross-sectional observational study (ATOPE study). Sci Rep. 2022 Sep 8;12(1):15217. doi: 10.1038/s41598-022-18706-7.
Gonzalez-Santos A, Lopez-Garzon M, Gil-Gutierrez R, Salinas-Asensio MDM, Postigo-Martin P, Cantarero-Villanueva I. Nonlinear, Multicomponent Physical Exercise With Heart Rate Variability-Guided Prescription in Women With Breast Cancer During Treatment: Feasibility and Preliminary Results (ATOPE Study). Phys Ther. 2023 Sep 1;103(9):pzad070. doi: 10.1093/ptj/pzad070.
Primary Completion
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 6, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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