A randomized trial to evaluate the impact of exercise-based cardiac rehabilitation for the prevention of chemotherapy-induced cardiotoxicity in patients with breast cancer: ONCORE study protocol
Abstract Background Anthracyclines and monoclonal antibodies against human epidermal growth factor receptor-2 (HER2) are frequently used to treat breast cancer but they are associated with risk of developing cardiotoxicity. Implementation of cardioprotective strategies as part of breast cancer treat...
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| Format: | Article |
| Language: | English |
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BMC
2021-04-01
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| Series: | BMC Cardiovascular Disorders |
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| Online Access: | https://doi.org/10.1186/s12872-021-01970-2 |
| _version_ | 1818849783825039360 |
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| author | Estíbaliz Díaz-Balboa Violeta González-Salvado Beatriz Rodríguez-Romero Amparo Martínez-Monzonís Milagros Pedreira-Pérez Patricia Palacios-Ozores Rafael López-López Carlos Peña-Gil José R. González-Juanatey |
| author_facet | Estíbaliz Díaz-Balboa Violeta González-Salvado Beatriz Rodríguez-Romero Amparo Martínez-Monzonís Milagros Pedreira-Pérez Patricia Palacios-Ozores Rafael López-López Carlos Peña-Gil José R. González-Juanatey |
| author_sort | Estíbaliz Díaz-Balboa |
| collection | DOAJ |
| description | Abstract Background Anthracyclines and monoclonal antibodies against human epidermal growth factor receptor-2 (HER2) are frequently used to treat breast cancer but they are associated with risk of developing cardiotoxicity. Implementation of cardioprotective strategies as part of breast cancer treatment are needed. To date, a limited number of studies have examined the effectiveness of cardiac rehabilitation programs or exercise programs in the prevention of cardiotoxicity through an integral assessment of cardiac function. The ONCORE study proposes an exercise-based cardiac rehabilitation program as a non-pharmacological tool for the management of chemotherapy-induced cardiotoxicity. Methods The study protocol describes a prospective, randomized controlled trial aimed to determine whether an intervention through an exercise-based CR program can effectively prevent cardiotoxicity induced by anthracyclines and/or anti-HER2 antibodies in women with breast cancer. Three hundred and forty women with breast cancer at early stages scheduled to receive cardiotoxic chemotherapy will be randomly assigned (1:1) to participation in an exercise-based CR program (intervention group) or to usual care and physical activity recommendation (control group). Primary outcomes include changes in left ventricular ejection fraction and global longitudinal strain as markers of cardiac dysfunction assessed by transthoracic echocardiography. Secondary outcomes comprise levels of cardiovascular biomarkers and cardiopulmonary function through peak oxygen uptake determination, physical performance and psychosocial status. Supervised exercise program-related outcomes including safety, adherence/compliance, expectations and physical exercise in- and out-of-hospital are studied as exploratory outcomes. Transthoracic echocardiography, clinical test and questionnaires will be performed at the beginning and two weeks after completion of chemotherapy. Discussion The growing incidence of breast cancer and the risk of cardiotoxicity derived from cancer treatments demand adjuvant cardioprotective strategies. The proposed study may determine if an exercise-based CR program is effective in minimizing chemotherapy-induced cardiotoxicity in this population of women with early-stage breast cancer. The proposed research question is concrete, with relevant clinical implications, transferable to clinical practice and achievable with low risk. Trial registration ClinicalTrials.gov Identifier: NCT03964142. Registered on 28 May 2019. Retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT03964142 |
| first_indexed | 2024-12-19T06:38:44Z |
| format | Article |
| id | doaj.art-c2e13b96cba242a4a63e7c7908963062 |
| institution | Directory Open Access Journal |
| issn | 1471-2261 |
| language | English |
| last_indexed | 2024-12-19T06:38:44Z |
| publishDate | 2021-04-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cardiovascular Disorders |
| spelling | doaj.art-c2e13b96cba242a4a63e7c79089630622022-12-21T20:32:10ZengBMCBMC Cardiovascular Disorders1471-22612021-04-0121111210.1186/s12872-021-01970-2A randomized trial to evaluate the impact of exercise-based cardiac rehabilitation for the prevention of chemotherapy-induced cardiotoxicity in patients with breast cancer: ONCORE study protocolEstíbaliz Díaz-Balboa0Violeta González-Salvado1Beatriz Rodríguez-Romero2Amparo Martínez-Monzonís3Milagros Pedreira-Pérez4Patricia Palacios-Ozores5Rafael López-López6Carlos Peña-Gil7José R. González-Juanatey8Cardiology Department, Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), University Clinical Hospital of Santiago de Compostela (SERGAS)Cardiology Department, Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), University Clinical Hospital of Santiago de Compostela (SERGAS)Psychosocial Intervention and Functional Rehabilitation Research Group, Department of Physiotherapy, Medicine and Biomedical Sciences, Faculty of Physiotherapy, University of A CoruñaCardiology Department, Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), University Clinical Hospital of Santiago de Compostela (SERGAS)Cardiology Department, Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), University Clinical Hospital of Santiago de Compostela (SERGAS)Health Research Institute of Santiago de Compostela (IDIS)Health Research Institute of Santiago de Compostela (IDIS)Cardiology Department, Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), University Clinical Hospital of Santiago de Compostela (SERGAS)Cardiology Department, Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), University Clinical Hospital of Santiago de Compostela (SERGAS)Abstract Background Anthracyclines and monoclonal antibodies against human epidermal growth factor receptor-2 (HER2) are frequently used to treat breast cancer but they are associated with risk of developing cardiotoxicity. Implementation of cardioprotective strategies as part of breast cancer treatment are needed. To date, a limited number of studies have examined the effectiveness of cardiac rehabilitation programs or exercise programs in the prevention of cardiotoxicity through an integral assessment of cardiac function. The ONCORE study proposes an exercise-based cardiac rehabilitation program as a non-pharmacological tool for the management of chemotherapy-induced cardiotoxicity. Methods The study protocol describes a prospective, randomized controlled trial aimed to determine whether an intervention through an exercise-based CR program can effectively prevent cardiotoxicity induced by anthracyclines and/or anti-HER2 antibodies in women with breast cancer. Three hundred and forty women with breast cancer at early stages scheduled to receive cardiotoxic chemotherapy will be randomly assigned (1:1) to participation in an exercise-based CR program (intervention group) or to usual care and physical activity recommendation (control group). Primary outcomes include changes in left ventricular ejection fraction and global longitudinal strain as markers of cardiac dysfunction assessed by transthoracic echocardiography. Secondary outcomes comprise levels of cardiovascular biomarkers and cardiopulmonary function through peak oxygen uptake determination, physical performance and psychosocial status. Supervised exercise program-related outcomes including safety, adherence/compliance, expectations and physical exercise in- and out-of-hospital are studied as exploratory outcomes. Transthoracic echocardiography, clinical test and questionnaires will be performed at the beginning and two weeks after completion of chemotherapy. Discussion The growing incidence of breast cancer and the risk of cardiotoxicity derived from cancer treatments demand adjuvant cardioprotective strategies. The proposed study may determine if an exercise-based CR program is effective in minimizing chemotherapy-induced cardiotoxicity in this population of women with early-stage breast cancer. The proposed research question is concrete, with relevant clinical implications, transferable to clinical practice and achievable with low risk. Trial registration ClinicalTrials.gov Identifier: NCT03964142. Registered on 28 May 2019. Retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT03964142https://doi.org/10.1186/s12872-021-01970-2Breast cancerCardiotoxicityCardiac rehabilitationExerciseCardio-oncologyAnthracyclines |
| spellingShingle | Estíbaliz Díaz-Balboa Violeta González-Salvado Beatriz Rodríguez-Romero Amparo Martínez-Monzonís Milagros Pedreira-Pérez Patricia Palacios-Ozores Rafael López-López Carlos Peña-Gil José R. González-Juanatey A randomized trial to evaluate the impact of exercise-based cardiac rehabilitation for the prevention of chemotherapy-induced cardiotoxicity in patients with breast cancer: ONCORE study protocol BMC Cardiovascular Disorders Breast cancer Cardiotoxicity Cardiac rehabilitation Exercise Cardio-oncology Anthracyclines |
| title | A randomized trial to evaluate the impact of exercise-based cardiac rehabilitation for the prevention of chemotherapy-induced cardiotoxicity in patients with breast cancer: ONCORE study protocol |
| title_full | A randomized trial to evaluate the impact of exercise-based cardiac rehabilitation for the prevention of chemotherapy-induced cardiotoxicity in patients with breast cancer: ONCORE study protocol |
| title_fullStr | A randomized trial to evaluate the impact of exercise-based cardiac rehabilitation for the prevention of chemotherapy-induced cardiotoxicity in patients with breast cancer: ONCORE study protocol |
| title_full_unstemmed | A randomized trial to evaluate the impact of exercise-based cardiac rehabilitation for the prevention of chemotherapy-induced cardiotoxicity in patients with breast cancer: ONCORE study protocol |
| title_short | A randomized trial to evaluate the impact of exercise-based cardiac rehabilitation for the prevention of chemotherapy-induced cardiotoxicity in patients with breast cancer: ONCORE study protocol |
| title_sort | randomized trial to evaluate the impact of exercise based cardiac rehabilitation for the prevention of chemotherapy induced cardiotoxicity in patients with breast cancer oncore study protocol |
| topic | Breast cancer Cardiotoxicity Cardiac rehabilitation Exercise Cardio-oncology Anthracyclines |
| url | https://doi.org/10.1186/s12872-021-01970-2 |
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