Randomized Controlled Trial on Comprehensive Exercise-based Cardiac Rehabilitation Programs for the Prevention of Anthracyclines and/or Anti-HER2 Antibodies-induced Cardiotoxicity in Breast Cancer

Brief Summary

Detailed Description

Cardiovascular toxicity caused by chemotherapy is the leading cause of death in patients who survive cancer. Physical exercise during chemotherapy has shown to improve quality of life and decrease the risk of death. The objective of this project is to determine whether an intervention through a comprehensive cardiac rehabilitation program including supervised physical exercise is able to prevent anthracyclines and / or anti-HER-2 antibodies-induced cardiotoxicity in women with breast cancer. For this purpose, the investigators intend to conduct a randomized controlled study including female patients managed under the same cardiotoxicity prevention protocol (clinical, laboratory and echocardiographic follow-up assessment). Patients will be randomized to a non-pharmacological intervention (participation in a multidisciplinary cardiac rehabilitation program with supervised exercise training) or control (conventional management and physical activity recommendation)\*. The investigators hypothesize that a cardiac rehabilitation program may limit chemotherapy-induced cardiotoxicity in women with breast cancer, improve cardiac remodeling assessed by echocardiography and enhance their global cardiovascular risk profile to a greater extent, compared to control group. \* OF NOTE: Due to the COVID-19 pandemics, several modifications to the original protocol were introduced for safety reasons or motivated by the health situation, namely: 1. Intervention: Change from centre-based to telematic supervised exercise training sessions provided within the cardiac rehabilitation program (intervention group) 2. Secondary outcome 4: Change in functional capacity assessed by conventional ergometry or cardiopulmonary exercise test OR the 6-minute walking test (metabolic equivalents: METs or peak oxygen consumption: VO2) 3. Recruiting centres: One centre (Hospital Universitari Vall d'Hebron) withdrew from the study due to the impossibility of assuming its execution.

Primary Outcomes

Secondary Outcomes

• Change in localized lower limb functional capacity assessed by number of repetitions performed within 30 seconds in the sit-to-stand test(Baseline and at the end of the study at an average of 18 months)
• Change in shoulder functional capacity assessed by range of degrees in shoulder movement by goniometry(Baseline and at the end of the study at an average of 18 months)
• Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors(Baseline and at the end of the study at an average of 18 months)
• Change in anthropometric parameters: weight in kg(Baseline and at the end of the study at an average of 18 months)
• Change in biomarkers: haemoglobin(Baseline and at the end of the study at an average of 18 months)
• Change in upper limb strength measured by dynamometry (kg)(Baseline and at the end of the study at an average of 18 months)
• Change in anthropometric parameters: height in cm(Baseline and at the end of the study at an average of 18 months)
• Change in anthropometric parameters: body mass index (BMI) in kg/m^2(Baseline and at the end of the study at an average of 18 months)
• Change in anthropometric parameters: abdominal circumference in cm(Baseline and at the end of the study at an average of 18 months)
• Change in resting heart rate measured by pulse oximetry (beats per min)(Baseline and at the end of the study at an average of 18 months)
• Change in biomarkers: troponin(Baseline and at the end of the study at an average of 18 months)
• Change in global functional capacity assessed by conventional ergometry, cardiopulmonary exercise testing (CPET) or the 6-minute walking test (6MWT).(Baseline and at the end of the study at an average of 18 months)
• Change in biomarkers NT-ProBNP(Baseline and at the end of the study at an average of 18 months)
• Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire(Baseline and at the end of the study at an average of 18 months)
• Change in shoulder pain and disability assessed by the SPADI (shoulder pain and disability index (SPADI) questionnaire(Baseline and at the end of the study at an average of 18 months)
• Change in resting blood pressure (mmHg) measured by sphygmomanometer(Baseline and at the end of the study at an average of 18 months)
• Change in physical activity assessed by the score in the Godin Leisure Test Exercise Questionnaire (GLTEQ)(Baseline and at study completion at an average of 18 months)
• Change in lymphedema assessed by perimeter of the upper limb by cirtometry (cm), stage and grade(Baseline after surgery and 2-4 weeks after the end of chemotherapy (at an average of 12 to 15 months))
• Change in tolerance to chemotherapy: number of participants with significant cardiovascular and non-cardiovascular adverse effects throughout the study(Every 3 months during study completion and at the end of the study at an average of 18 months)
• Change in dietary pattern as assessed by the PREDIMED (PREvención con DIeta MEDiterránea) questionnaire(Baseline and at the end of the study at an average of 18 months)
• Change in the score for anxiety assessed by the Zigmond and Snaith questionnaire to rate depression and anxiety(Baseline and at study completion, plus at the end of training (at an average of 12 to 15 months) in the intervention group)
• Change in physical activity (minutes of dedicated physical activity)(Baseline and at study completion at an average of 18 months)
• Change in the score for depression assessed by Zigmond and Snaith questionnaire to rate anxiety and depression(Baseline and at study completion at an average of 18 months, plus at the end of training (at an average of 12 to 15 months) in the intervention group)