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

IF 1.1 Q3 SURGERY
Norman R. Williams , Sarah Williams , Muholan Kanapathy , Naghmeh Naderi , Vasileios Vavourakis , Afshin Mosahebi
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引用次数: 10

Abstract

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).

Abstract Image

乳腺癌辐射诱导纤维化:个体化风险估计和客观评估的观察性横断面试点研究方案
大约30%的乳腺癌患者在手术后要求乳房重建,但放射治疗对结果有负面影响。重建后放射治疗与更多的并发症相关,包括更严重的包膜挛缩和较差的美容效果。一般来说,如果在放疗后进行自体重建,则纤维化较少,因此外科医生通常会将重建推迟到放疗完成后。这种方法的缺点包括额外的手术、恢复、费用和延长的重建过程。需要随机临床试验来确定最佳方法。方法和分析这项横断面试点研究的目的是看看是否可行招募妇女,并收集所需的数据。这些信息将用于设计后续更大规模的研究,其目的是确定增加辐射诱导纤维化风险的因素,并利用这些因素开发个性化的风险预测工具,使临床医生和患者在讨论乳腺癌治疗时能够进行更知情的讨论。对风险因素的识别也将有助于开发将风险降至最低的方法,这将在纤维化是一个问题的其他医疗条件下得到应用。此外,该项目将开发评估纤维化的客观方法,并将确定纤维化对个体的心理和经济影响。更好地了解放射治疗对正常组织(如心脏和肺)的长期影响,也可能应用于其他存在纤维化问题的医疗条件。伦理和传播本研究已提交伦理批准(REC参考)。研究结果将通过在国家和国际会议、同行评审出版物、社交媒体和患者支持团体上的演讲向患者和临床医生提供。试验注册在ClinicalTrials.gov注册(REC批准后)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
自引率
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发文量
12
期刊介绍: IJS Protocols is the first peer-reviewed, international, open access journal seeking to publish research protocols across across the full breadth of the surgical field. We are aim to provide rapid submission to decision times whilst maintaining a high quality peer-review process.
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