Contemporary clinical trials · 2026
Rationale and design of a CArdiac Rehabilitation program on the Prevention of CardioTOXicity in Breast Cancer patients undergoing treatment with anthracyclines and/or trastuzumab (CARPTOX-BC) trial: a randomized, active control group, open-label trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Santa-Ana-Bayona Maria Jose, Ponce-Acosta Camila, Acosta-Gutierrez Gilberto H, Morales-Alvarez Pamela, Guerra Enrique C, Gonzalez-Trejo Alfonso, Espinosa-Fernandez Jose Rodrigo, Solis Flores Nestor J, Ilarraza-Lomelí Hermes, Alexanderson-Rosas Erick, Leyva-López Yoana, Antonio-Villa Neftali Eduardo, Espinola-Zavaleta Nilda
Аннотация
BACKGROUND: Breast cancer (BC) remains a leading cause of cancer-related deaths among women. Administration of anthracyclines and/or anti-human epidermal growth factor receptor-2 (HER2) antibodies has been associated with chemotherapy-induced cardiotoxicity. Cardio-oncology rehabilitation programs aim to mitigate these outcomes. However, their preventive role in cancer therapy-related cardiac dysfunction (CTRCD) remains uncertain.
OBJECTIVES: To evaluate the effectiveness of a structured exercise program compared with only exercise recommendation in preventing CTRCD, defined by the 2022 European Society of Cardiology criteria, as a left ventricular ejection fraction above 50%, with a relative decrease in global longitudinal strain exceeding 15% from baseline and/or a newly detected elevation in cardiac troponin I or T or natriuretic peptides. Secondary outcomes include the impact on systolic and diastolic echocardiographic parameters, cardiometabolic biomarkers, quality of life, and exploring the role of traditional cardiovascular risk factors in CTRCD onset.
METHODS: CARPTOX-BC is a randomized, open-label clinical trial with an active control group. Women aged 18-70 years with stage I-III BC scheduled for neoadjuvant or adjuvant therapy with anthracyclines and/or trastuzumab will be eligible. The intervention includes three supervised out of five weekly aerobic and resistance exercise. A total of 284 participants will be randomized 1:1 to intervention or control arms.
RESULTS: Results will be disclosed at completion.
CONCLUSIONS: We expect a structured exercise program may reduce the incidence of CTRCD associated with anthracycline and/or HER2 antibody and provide a potential non-pharmacological therapy that could also enhance cardiometabolic markers and quality of life among this population.
TRIAL REGISTRATION: NCT06881940 (registered March 18th, 2025).
OBJECTIVES: To evaluate the effectiveness of a structured exercise program compared with only exercise recommendation in preventing CTRCD, defined by the 2022 European Society of Cardiology criteria, as a left ventricular ejection fraction above 50%, with a relative decrease in global longitudinal strain exceeding 15% from baseline and/or a newly detected elevation in cardiac troponin I or T or natriuretic peptides. Secondary outcomes include the impact on systolic and diastolic echocardiographic parameters, cardiometabolic biomarkers, quality of life, and exploring the role of traditional cardiovascular risk factors in CTRCD onset.
METHODS: CARPTOX-BC is a randomized, open-label clinical trial with an active control group. Women aged 18-70 years with stage I-III BC scheduled for neoadjuvant or adjuvant therapy with anthracyclines and/or trastuzumab will be eligible. The intervention includes three supervised out of five weekly aerobic and resistance exercise. A total of 284 participants will be randomized 1:1 to intervention or control arms.
RESULTS: Results will be disclosed at completion.
CONCLUSIONS: We expect a structured exercise program may reduce the incidence of CTRCD associated with anthracycline and/or HER2 antibody and provide a potential non-pharmacological therapy that could also enhance cardiometabolic markers and quality of life among this population.
TRIAL REGISTRATION: NCT06881940 (registered March 18th, 2025).
Предметные рубрики MeSH
HumansFemaleBreast NeoplasmsTrastuzumabAnthracyclinesCardiotoxicityMiddle AgedAdultCardiac RehabilitationQuality of LifeAgedRandomized Controlled Trials as TopicExercise TherapyAntineoplastic Combined Chemotherapy ProtocolsStroke VolumeYoung AdultAdolescentAntineoplastic Agents, ImmunologicalGlobal Longitudinal Strain