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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversidad de Granada

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Recently diagnosed with stage I-III breast cancer

Treatments predisposing to cardiotoxicity (anthracyclines, targeted therapies, radiotherapy)

Signed informed consent form

Medical authorisation to participate

Disqualifiers

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.).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 2 interventions
Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Cardiotoxicity

Echocardiography: left ventricular ejection fraction expressed as percentage.

Time frame
At diagnosis before treatments, after 6 months, and one year after diagnosis.
2

Systolic function

Echocardiography: Strain longitudinal global expressed as percentage.

Time frame
At diagnosis before treatments, after 6 months, and one year after diagnosis.

Secondary outcomes

1

Number of cardiovascular events

Clinical records registration expressed as number (N) of cardiovascular events.

Time frame
At diagnosis before treatments, after 6 months, and one year after diagnosis.
2

Comorbidities

Any chronic pathological condition different from the oncologic one will be registed by a clinical interview, an expressed in results as number (N) and type.

Time frame
At diagnosis before treatments, after 6 months, and one year after diagnosis.
3

Heart rate variability

Assessment of cardiac autonomic system balance by a Holter registration, registering the log-transformed root mean square of successive R-R intervals (lnRMSSD) and expressed as milliseconds (ms).

Time frame
At diagnosis before treatments, after 6 months, and one year after diagnosis.
4

Heart rate

Resting heart rate registration by a Holter, expressed as beats per minute (bpm).

Time frame
At diagnosis before treatments, after 6 months, and one year after diagnosis.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad de Granada

Lead sponsor

Instituto de Salud Carlos III

Collaborator

Hospital Clinico Universitario San Cecilio

Collaborator

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