Radiation-induced fibrosis in breast cancer: A protocol for an observational cross-sectional pilot study for personalised risk estimation and objective assessment

INTRODUCTION: About 30% of patients request breast reconstruction following surgery for breast cancer, but radiation therapy negatively influences the outcome. Post-reconstruction radiotherapy is associated with more complications, including more severe capsular contracture and inferior cosmetic results. In general, less fibrosis is seen if autologous reconstruction is performed after radiotherapy, so surgeons will often delay reconstruction until after radiotherapy is complete. Drawbacks to this approach include additional surgery, recuperation, cost, and an extended reconstructive process. Randomised clinical trials are required to determine the best approach. METHODS AND ANALYSIS: The aim of this cross-sectional pilot study is to see if it is feasible to recruit women, and gather the required data. This information will be used to design a subsequent, larger study whose aim is to identify factors that increase the risk of radiation-induced fibrosis, and use these to develop a personalised risk-prediction tool, to enable the clinician and patient to have a more informed discussion when treatment for breast cancer is being discussed. Identification of the risk factors will also enable the development of methods to minimise the risk, which would have applications in other medical conditions where fibrosis is a problem. In addition, the project will develop objective methods of assessing fibrosis, and will determine the psychological and economic impacts that fibrosis has affected individuals. A better understanding of the long-term effects of radiotherapy on normal tissues such as the heart and lungs may also have applications in other medical conditions where fibrosis is a problem. ETHICS AND DISSEMINATION: The study has been submitted for ethical approval (REC reference). Findings will be made available to patients and clinicians through presentations at national and international meetings, peer-reviewed publications, social media and patient support groups. TRIAL REGISTRATION: Registered on ClinicalTrials.gov (after REC approval).