Exercise as a diagnostic and therapeutic tool for preventing cardiovascular morbidity in breast cancer patients- the BReast cancer EXercise InTervention (BREXIT) trial protocol

• Published in: BMC cancer Vol. 20; no. 1; pp. 655 - 16
• Main Authors: Foulkes, Stephen J, Howden, Erin J, Antill, Yoland, Loi, Sherene, Salim, Agus, Haykowsky, Mark J, Daly, Robin M, Fraser, Steve F, La Gerche, Andre
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 14-07-2020; BioMed Central; BMC
• Subjects: Adjuvant chemotherapy; Adult; Aged; Anthracycline; Anthracyclines - adverse effects; Body composition; Bone composition; Bone density; Bone mineral density; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; Brexit; Cancer patients; Cancer Survivors - statistics & numerical data; Cancer therapies; Cardiac function; Cardiac reserve; Cardiotoxicity; Cardiotoxicity - diagnosis; Cardiotoxicity - etiology; Cardiotoxicity - therapy; Cardiovascular disease; Cardiovascular Diseases - chemically induced; Cardiovascular Diseases - diagnosis; Cardiovascular Diseases - prevention & control; Chemotherapy; Clinical trials; Cognitive ability; Contraindications; Diagnostic imaging; Disability; Drug therapy; Echocardiography; Exercise; Exercise therapy; Exercise Therapy - methods; Exercise training; Female; Fitness training programs; Follow-Up Studies; Health aspects; Heart failure; Humans; Magnetic resonance imaging; Medical prognosis; Medical research; Middle Aged; Morbidity; Mortality; Muscle strength; Patients; Physical activity; Physical fitness; Physical training; Physiological aspects; Prevention; Prognosis; Quality of life; Randomized Controlled Trials as Topic; Study Protocol; Ventricle; Womens health; Cardiac reserve; Cardiotoxicity; Exercise training; Anthracycline
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-020-07123-6

Anthracycline chemotherapy (AC) is an efficacious (neo) adjuvant treatment for early-stage breast cancer (BCa), but is associated with an increased risk of cardiac dysfunction and functional disability. Observations suggest that regular exercise may be a useful therapy for the prevention of cardiovascular morbidity but it is yet to be interrogated in a large randomised trial. The primary aims of this study are to: 1) determine if 12-months of ET commenced at the onset of AC can reduce the proportion of BCa patients with functional disability (peak VO
, < 18 ml/kg/min), and 2) compare current standard-of-care for detecting cardiac dysfunction (resting left-ventricular ejection fraction assessed from 3-dimensional echocardiography) to measures of cardiac reserve (peak exercise cardiac output assessed from exercise cardiac magnetic resonance imaging) for predicting the development of functional disability 12-months following AC. Secondary aims are to assess the effects of ET on VO2peak, left ventricular morphology, vascular stiffness, cardiac biomarkers, body composition, bone mineral density, muscle strength, physical function, habitual physical activity, cognitive function, and multidimensional quality of life.
One hundred women with early-stage BCa (40-75 years) scheduled for AC will be randomized to 12-months of structured exercise training (n = 50) or a usual care control group (n = 50). Participants will be assessed at baseline, 4-weeks following completion of AC (4-months) and at 12-months for all measures.
Women diagnosed with early-stage BCa have increased cardiac mortality. More sensitive strategies for diagnosing and preventing AC-induced cardiovascular impairment are critical for reducing cardiovascular morbidity and improving long-term health outcomes in BCa survivors.
Australia & New Zealand Clinical Trials Registry (ANZCTR), ID: 12617001408370 . Registered on 5th of October 2017.