Vascular Medicine Department, University Hospital Center - Toulouse, Toulouse, France.
Department of Oncological Surgery, University Hospital Center - Toulouse, Toulouse University Cancer Institute - Oncopole, Toulouse Cedex 9, France.
Clin Breast Cancer. 2024 Aug;24(6):533-540. doi: 10.1016/j.clbc.2024.05.009. Epub 2024 May 22.
This phase II trial sought to be the first of its kind to estimate the success rate of endermology in reducing breast cancer-related lymphedema.
ELOCS is a French, monocentric, randomized, open-label phase II trial. Patients were randomized to receive the following over a 5-day treatment period: standard intensive decongestant treatment (IDT) (bandages and manual lymphatic drainage MLD) (group 1); IDT including bandages, MLD, and Cellu M6 (group 2); and IDT including bandages and Cellu M6 (Group 3). The main endpoint was the success rate in each group, (reduction of at least 30% in the excess volume). We estimated that endermology treatment (groups 2 and 3) would be of interest successes occurred in at least 21 out of 31 patients.
A total of 93 patients were included (31 patients in each of the 3 groups). The median age was 64.5 years (IQR: [56.4-71.3]). Patients were treated with mastectomy (n = 35), axillary lymphadenectomy (n = 80), radiotherapy (n = 91), and chemotherapy (n = 68). The mean relative reduction in excess volume was 38% in group 1, 33% in group 2, and 34% in group 3. Success rate was 58.1% in group 1 (18/31, P = ,0237), 51.6% (16/31, P = ,5) in group 2, and 64.5% (20/31, P = ,075) in group 3. In the LPG groups (2 and 3), 10/62 (16%) patients found LPG painful and 9/62 (15%) patients considered it to be unpleasant.
Even though the critical threshold of 21 successes was not met, this study was the first to validate a standardized and reproducible endermology protocol.
本 II 期试验旨在首次评估表皮运动学治疗乳腺癌相关淋巴水肿的成功率。
ELOCS 是一项法国的、单中心、随机、开放标签的 II 期试验。患者在 5 天的治疗期内随机接受以下治疗：标准强化消肿治疗（IDT）（绷带和手动淋巴引流 MLD）（第 1 组）；IDT 包括绷带、MLD 和 Cellu M6（第 2 组）；以及 IDT 包括绷带和 Cellu M6（第 3 组）。主要终点是每组的成功率，（过量体积减少至少 30%）。我们估计表皮运动学治疗（第 2 组和第 3 组）将是有意义的成功，至少有 21 例患者中的 31 例发生。
共纳入 93 例患者（每组 31 例）。中位年龄为 64.5 岁（IQR：[56.4-71.3]）。患者接受了乳房切除术（n=35）、腋窝淋巴结切除术（n=80）、放疗（n=91）和化疗（n=68）。第 1 组过量体积的平均相对减少率为 38%，第 2 组为 33%，第 3 组为 34%。第 1 组的成功率为 58.1%（18/31，P=，0237），第 2 组为 51.6%（16/31，P=，5），第 3 组为 64.5%（20/31，P=，075）。在 LPG 组（第 2 组和第 3 组）中，10/62（16%）例患者认为 LPG 疼痛，9/62（15%）例患者认为 LPG 不愉快。
尽管未达到 21 例成功的关键阈值，但本研究首次验证了标准化和可重复的表皮运动学方案。
