Exercise-based Cardiac Rehabilitation for the Prevention of Breast Cancer Chemotherapy-induced Cardiotoxicity
Condition: Cardiotoxicity; Cardiac Rehabilitation
MeSH terms: Cardiotoxicity
Study type: Interventional

Summary: 
      This project aims to determine whether a comprehensive cardiac rehabilitation program
      including supervised exercise training is able to prevent cardiotoxicity during treatment
      with anthracyclines and / or anti-HER-2 antibodies in women with breast cancer. Participants
      will be randomly allocated to cardiac rehabilitation (intervention group) or conventional
      management with physical exercise recommendation (control group).
    

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.
    

Intervention name(s): Cardiac rehabilitation
Intervention type(s): Other
Intervention description(s): Integrated cardiac rehabilitation program that includes supervised exercise training*.
* Due to the COVID-19 pandemic, supervised physical exercise training had to be conducted telematically (through live guided training sessions conducted online, with the same design, frequency, and dosage of exercise).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Chemotherapy; Anthracyclines; Trastuzumab; Pertuzumab; Antibodies, Monoclonal, Humanized; Breast Cancer; Exercise therapy