Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 14, 2021
Date Accepted: Nov 27, 2021
Date Submitted to PubMed: Apr 22, 2022
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Early Detection of Cardiotoxicity from Systemic and Radiation Therapy in Breast Cancer Patients (CardioTox Breast): Protocol Design of a Multi-Institutional Prospective Study
ABSTRACT
Background:
Incidence of breast cancer is rising worldwide. Recent advances in systemic and local treatments have significantly improved survival rates of early breast cancer patients. In the last decade, great attention has been paid to prevention and early detection of cardiotoxicity induced by breast cancer treatments. Systemic therapy-related cardiac toxicities have been extensively studied. Radiotherapy, an essential component of breast cancer treatment, can also increase the risk of heart diseases. Consequently, it is important to balance the expected benefits of cancer treatment with cardiovascular risk and to identify strategies to prevent cardiotoxicity and improve long-term outcomes and quality of life for these patients.
Objective:
The Cardiotox study aims to investigate the use of cardiac magnetic resonance imaging and identify associated circulating biomarkers to assess early tissue changes in chemo- and radiation-induced cardiotoxicity in the time window of 12 months after the end of radiotherapy in breast cancer patients.
Methods:
The Cardiotox Breast trial is a multicenter, observational prospective longitudinal study. The aim is to identify any change in circulating biomarkers and cardiac imaging (based on cardiovascular magnetic resonance and echocardiography), to predict the incidence of cardiotoxicity and to detect it when is still subclinical and reversible. We plan to enrol 150 women with stage I-III, unilateral, breast cancer treated with breast conserving surgery and planned to receive radiotherapy with or without systemic therapy.
Results:
This study details the protocol of the CardioTox Breast trial. As of September 2020, thirteen patients have been enrolled by the Oncology Institute of Southern Switzerland and 4 patients by Fondazione IRCCS Policlinico San Matteo, Italy. Results of the present study will not be published until data are mature for the final analysis of the primary study endpoint.
Conclusions:
The CardioTox Breast study is designed to investigate the effects of systemic and radiation therapy on myocardial function and structure, thus providing additional evidence on whether CMR is the optimal screening imaging for cardiotoxicity. Clinical Trial: ClinicalTrials.gov Identifier: NCT04790266
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