Implementing fencing as adapted physical activity in non-metastatic breast cancer patients: design and early rehabilitation strategy of the FENICE study protocol

M. Berretta, Daniele Garozzo, Calogero Foti, Mario Roselli, M. Materazzo, Giulia Vita, Ferdinando Iellamo, Marco Scordari, Giordana Di Mauro, Giovanna Spatari, Alessandro Ottaiano, A. Noce, Marco Pelicciaro, Alessia Bignucolo, Gianluca Vanni, O. Buonomo
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Abstract

Improving prognosis of BC patients has drawn the attention of health care professionals on disease related long-term side effects and on the multiple treatments BC patients must undergo. Despite advances in procedures, surgery still has multiple detrimental effects, including pain, edema, and limited mobility. For this reason, fostering adapted physical activity (APA) and healthy lifestyle (including a balanced diet and weight management) should become an everyday purpose of healthcare professionals. Fencing may be a well-suited activity to counteract fatigue, pain, and limited arm mobility.The FENICE study is a mono-center, randomized clinical trial targeting women with BC stages I-III within four weeks from BC surgery. Participants in the control arm will receive the usual recommendations based on the good clinical practice guidelines. In the study arm, participants will be treated with the usual clinical and therapeutic recommendations together with APA and correct lifestyle suggestions.The primary objective of the study is to compare whether implementation of APA and healthy lifestyle in BC patient after surgery will result in an overall improvement of physical and mental status.Fencing and its early application in postoperative period may represent a feasible strategy to be implemented in the rehabilitation journey of BC patients.The study protocol FENICE has been approved by an Italian Ethics Committee on May 2023 (R.S 100.23 5th May 2023).
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在非转移性乳腺癌患者中开展击剑运动:FENICE 研究方案的设计和早期康复策略
BC 患者预后的改善引起了医护人员对与疾病相关的长期副作用以及 BC 患者必须接受的多种治疗的关注。尽管手术程序不断进步,但手术仍会产生多种不利影响,包括疼痛、水肿和活动受限。因此,促进适应性体育活动(APA)和健康的生活方式(包括均衡饮食和体重管理)应成为医护人员的日常目标。FENICE 研究是一项单中心、随机临床试验,对象是 BC 手术后四周内的 BC I-III 期女性患者。对照组的参与者将接受基于良好临床实践指南的常规建议。该研究的主要目的是比较在 BC 患者术后实施 APA 和健康生活方式是否会全面改善其身体和精神状态。剑术及其在术后的早期应用可能是在 BC 患者康复过程中实施的一种可行策略。FENICE 研究方案已于 2023 年 5 月获得意大利伦理委员会批准(R.S 100.23,2023 年 5 月 5 日)。
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