Preventing Breast Cancer Therapy-related Cardiovascular Toxicity With a Daily-adapted Program With Mhealth Support

NCT06518200 | Not Yet Recruiting

• 1 other identifier: PI23/01646
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Female

Keywords

Breast Neoplasms; Cancer therapy-related cardiovascular toxicity; Physical Exercise; Prevention; Quality of life; Rehabilitation; Telemedicine; Health related lifestyle

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (27)

• 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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Health recommendations (educational videos) + Individualised exercise intervention

Behavioral: Individualised health recommentations; Behavioral: Individualised physical exercise program

Control Group

OTHER

Health recommendations (educational videos)

Behavioral: General health recommendations

Interventions

General health recommendations BEHAVIORAL

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.

Control Group

Individualised health recommentations BEHAVIORAL

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.

Intervention Group

Individualised physical exercise program BEHAVIORAL

Follow-up of an individualised exercise program adjusted by daily monitoring of the level of physical, physiological and psychological condition.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recently diagnosed with stage I-III breast cancer
• Treatments predisposing to cardiotoxicity (anthracyclines, targeted therapies, radiotherapy)
• Signed informed consent form
• Medical authorisation to participate
• Smartphone user level

You may not qualify if:

• Patient underwent previous cancer treatments.
• Patients were previously diagnosed with cancer
• Pregnant patients. Patients performing other type of therapeutic exercise at diagnosis time with an intake \>or = to 150 moderate-intensity or 75 min of vigorous-intensity a day
• Therapeutic exercise practice not recommended because psychiatric or cognitive disorders or cute or chronic condition that prevents exercise (advanced lung disease, oxygen requirement, stenosis \>70%, metastasis etc.).

Sponsors & Collaborators

• Universidad de Granada: lead
• Instituto de Salud Carlos III: collaborator
• Hospital Clinico Universitario San Cecilio: collaborator

Study Sites (1)

University of Granada

Granada, 18016, Spain

Location

Related Publications (4)

• 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.

  PMID: 33528004 BACKGROUND

• 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.

  PMID: 33963594 BACKGROUND

• 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.

  PMID: 36076044 RESULT

• 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.

  PMID: 37347987 RESULT

Related Links

• S. Moreno-Gutierrez et al., "ATOPE+: An mHealth System to Support Personalized Therapeutic Exercise Interventions in Patients With Cancer," in IEEE Access, vol. 9, pp. 16878-16898, 2021, doi: 10.1109/ACCESS.2021.3049398.

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Irene Cantarero Villanueva, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Cantarero Villanueva, PhD

CONTACT

637007250; irenecantarero@ugr.es

Isabel Blancas López-Barajas, PhD

CONTACT

958257235; iblancas@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double masking until end of intervention and evaluations
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 24, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)