Preventing Breast Cancer Therapy-related Cardiovascular Toxicity With a Daily-adapted Program With Mhealth Support
NCT Number: NCT06518200
Acronym: ATOPE-PRO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer Female
Interventions: BEHAVIORAL: Individualised health recommentations|BEHAVIORAL: General health recommendations|BEHAVIORAL: Individualised physical exercise program
Sponsor: Universidad de Granada
Collaborators: Instituto de Salud Carlos III|Hospital Clinico Universitario San Cecilio
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2025-01-01
Completion Date: 2026-12-31
Locations: University of Granada, Granada, 18016, Spain

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.

Primary Outcome Measures: 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 Outcome Measures: Number of cardiovascular events, Clinical records registration expressed as number (N) of cardiovascular events., At diagnosis before treatments, after 6 months, and one year after diagnosis.|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., At diagnosis before treatments, after 6 months, and one year after diagnosis.|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)., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Heart rate, Resting heart rate registration by a Holter, expressed as beats per minute (bpm)., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Blood pressure, Systolic and diastolic blood pressure levels registration after evaluation by a digital sphygmomanometer, expressed as mmHg (mercury millimetres)., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Cardiac damage, Collection of capillary samples for Cardiac troponin T measurement, with results expressed as ng/L, indicating higher values thatn 40ng/L cardiotoxicity or other cardiac injuries., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Cardiac Damage, Blood test for high-sensitivity cardiac troponin I evaluation, considering normal values below 14ng/L., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Endothelial status, By registering ascorbic acid levels provided by blood test, being the reference range of 0.6-2 mg/dL, At diagnosis before treatments, after 6 months, and one year after diagnosis.|Cardiorespiratory Fitness, A Treadmill Ergometric Test will be performed in order to evaluate VO2 peak values, calcultated as the highest VO2 value in liters per minute during the test. Cut-off points will be set at low(\<13 mL·kg-1·min-1), moderate (13.916.9 mL·kg-1·min-1), and high (≥17 mL·kg-1·min-1), considering a minimal clinically important difference a 6% of Vo2 peak change., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Quadriceps muscle thickness, Quadriceps muscular ecography will be used, expressing results as centimeters (cm)., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Body Fat Mass, Bioelectrical impedance analysis (BIA) will be perfomerd by using an Inbody 720 for measuring body fat mass, expressed in kilograms (kg)., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Height, Bioelectrical impedance analysis (BIA) will be perfomerd by using an Inbody 720 for measuring body fat mass, expressed in kilograms (kg).

A tallimeter will be used to register height, expressed in meters (m)., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Weight, Bioelectrical impedance analysis (BIA) will be perfomerd by using an Inbody 720 for measuring body weight, expressed in kilograms (kg)., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Body Mass Index, By registering height and weight, Body mass index (BMI) will be calculated as weight (kg)/ height (m\^2), expressed as kg/m\^2., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Body Fat Percentage, Bioelectrical impedance analysis (BIA) will be perfomerd by using an Inbody 720 for measuring body fat percentage, expressed as a percentage (%)., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Physical Activity level, International physical activity questionnaire (IPAQ) will be used to report physical activity levels of participants, expressed as Metabolic Equivalent of Task per week (METs/week)., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Sleep duration, Sleep duration time, expressed as hours (h), will be recorded by activity bracelets., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Fatigue, A Likert 0-10 scale will be applied, indicating 0 the absence of the symptom, and a 10 'the most' of the symptom., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Total Cholesterol, Total cholesterol (TC) will be obtained through blood test and expressed as mg/dl., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Triglycerides level, Obtained through blood test and expressed as mmol/L., At diagnosis before treatments, after 6 months, and one year after diagnosis.|LDL-C level, Low-density lipoprotein cholesterol will be obtained through blood test and expressed as mg/dl., At diagnosis before treatments, after 6 months, and one year after diagnosis.|HDL-C level, High-density lipoprotein cholesterol will be obtained through blood test and expressed as mg/dl., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Total antioxidant capacity, Oxidative Stress TAC biomarker will be assessed by blood test, expressing its results as mM-TE units., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Oxidative status, Thiobarbituric Acid Reactive Substances concentration Oxidative Stress TBARS biomarker will be assessed by blood test, being results expressed as the number of milligrammes of malonaldehyde per kilogramme of sample, At diagnosis before treatments, after 6 months, and one year after diagnosis.|Epigenetic profile, miRNA expression profile quantification: analysis of miRNA expression profile by massive sequencing with specific equipment, reporting changes in expression pre and post intervention as Log2 fold change (Log2FC)., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Inflammatory status, C-reactive protein levels obtained by blood samples, expressed as mg/dl., At diagnosis before treatments, after 6 months, and one year after diagnosis.|Immune status, Interleuquin-6 (IL-6) levels obtained by blood samples, expressed as pg/ml., At diagnosis before treatments, after 6 months, and one year after diagnosis.