The REBECCA Study
Research type
Research Study
Full title
Rehabilitation for cardiotoxicity in breast cancer patients: the REBECCA Study. A pilot study
IRAS ID
345430
Contact name
Laura Kenny
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
1 years, 3 months, 30 days
Research summary
Outcomes for breast cancer patients have significantly improved in the UK. Chemotherapy is used in approximately 40% of patients with breast cancer, however the side effects can lead to long lasting cardiovascular morbidity and mortality. There is an urgent need to improve patients’ quality of life (QOL) and longevity to prevent long-term illness. This is particularly relevant in ethnic minorities of South Asian and African Caribbean heritage who have higher prevalence of cardiovascular disease (Raleigh 2023).
Cancer therapy-related cardiovascular toxicity, a known complication of breast cancer treatment due to treatment with anthracycline, targeted treatment or immunotherapy. There is also emerging evidence of an increased risk of cardiovascular event from treatment with endocrine therapy, aromatase inhibitors. Several recommendations for its diagnosis, oncology and pharmacological management have since emerged. However there lacks conclusive evidence on cardio-preventive strategies to manage cardiotoxicity in breast cancer patients. Cardiac rehabilitation, an individualised exercise, education and support program, has been the backbone for recovery for patients diagnosed with a cardiac event. Further, exercise has positive outcomes on physical fitness, muscle strength and QOL for patients with cardiovascular risk factors and for patient diagnosed with cancer. More recently, an expert statement suggest a model for cardio-oncology rehabilitation as a preventive strategy to support patients who experience cardiotoxicity.
This study aims to explore the feasibility of implementing a rehabilitation exercise intervention for breast cancer patients treated with neoadjuvant or adjuvant treatment including chemotherapy, targeted therapy, immunotherapy or endocrine therapy. The study aims to evaluate the outcomes of intervention on cardiovascular health, body composition, physical fitness and quality of life. Due to ethnic minorities diagnosed with breast cancer having poorer outcomes, lack of recruitment of ethnic minorities into clinical trials nationally and the diverse population at the recruitment centre, ICHT, we propose to recruit a minimum of 20% of patients from an ethnic minority background.
REC name
London - Brent Research Ethics Committee
REC reference
25/LO/0140
Date of REC Opinion
3 Mar 2025
REC opinion
Favourable Opinion