De Vrieze Tessa, Vos Lore, Gebruers Nick, Tjalma Wiebren A A, Thomis Sarah, Neven Patrick, Nevelsteen Ines, De Groef An, Vandermeeren Liesbeth, Belgrado Jean-Paul, Devoogdt Nele
KU Leuven - University of Leuven, Department of Rehabilitation Sciences, Leuven, Belgium; University of Antwerp, Department of Rehabilitation Sciences and Physiotherapy, MOVANT, Antwerp, Belgium.
University of Antwerp, Department of Rehabilitation Sciences and Physiotherapy, MOVANT, Antwerp, Belgium; University of Antwerp & Antwerp University Hospital, Multidisciplinary Oedema Clinic, Antwerp, Belgium.
Eur J Obstet Gynecol Reprod Biol. 2018 Feb;221:177-188. doi: 10.1016/j.ejogrb.2017.12.023. Epub 2017 Dec 16.
Lymphoedema is a dreadful complication following breast cancer therapy. According to the International Society of Lymphology, the consensus treatment for breast cancer-related lymphoedema (BCRL) is the decongestive lymphatic therapy. This is a two-phase treatment and combines different treatment modalities including skin care, manual lymphatic drainage (MLD), compression therapy and exercise. However, the additional effect of MLD is debated since pooled data only demonstrated a limited non-significant additional value. A possible explanation is that in previous studies MLD has been applied blind, without knowledge of patient-specific lymphatic routes of transport. In addition, the MLD hand manoeuvres used by the therapists in previous studies, possibly did not optimally stimulate lymphatic transport. Recently, near-infrared fluorescence imaging has been introduced to visualise the superficial lymphatic network which allows MLD at the most needed location. The aim of the present study is to determine the effectiveness of the fluoroscopy-guided MLD, additional to the other parts of the decongestive lymphatic therapy and compared to the traditional or a placebo MLD, in the treatment of BCRL.
A three-arm double-blinded randomised controlled trial will be conducted in different university hospitals in Belgium. Based on a sample size calculation, 201 participants with chronic BCRL stage 1 or 2 of the arm or hand, with at least 5% difference between both sides (corrected for hand dominance) need to be recruited. All participants receive the standard treatment: skin care, compression therapy and exercises. The intervention group additionally receives fluoroscopy-guided MLD. One control group additionally receives the traditional 'blind' MLD and a second control group receives a placebo MLD. All subjects receive 3 weeks of daily intensive treatments and 6 months of maintenance treatment. Follow-up period is 6 months. The primary outcomes are the reduction in lymphoedema volume of the arm/hand and the change in stagnation of lymph fluid at level of the shoulder/trunk.
淋巴水肿是乳腺癌治疗后一种可怕的并发症。根据国际淋巴学协会的说法，乳腺癌相关淋巴水肿（BCRL）的共识治疗方法是消肿淋巴治疗。这是一个两阶段的治疗方法，结合了不同的治疗方式，包括皮肤护理、手动淋巴引流（MLD）、压迫疗法和运动。然而，MLD的额外效果存在争议，因为汇总数据仅显示出有限的非显著额外价值。一个可能的解释是，在先前的研究中，MLD是盲目应用的，并不了解患者特定的淋巴运输途径。此外，先前研究中治疗师使用的MLD手部操作可能并未最佳地刺激淋巴运输。最近，近红外荧光成像已被引入以可视化浅表淋巴网络，从而能够在最需要的位置进行MLD。本研究的目的是确定在消肿淋巴治疗的其他部分基础上，与传统或安慰剂MLD相比，荧光透视引导下的MLD在治疗BCRL中的有效性。
将在比利时不同的大学医院进行一项三臂双盲随机对照试验。根据样本量计算，需要招募201名手臂或手部处于慢性BCRL 1期或2期、两侧至少有5%差异（校正手优势）的参与者。所有参与者都接受标准治疗：皮肤护理、压迫疗法和运动。干预组额外接受荧光透视引导下的MLD。一个对照组额外接受传统的“盲目”MLD，另一个对照组接受安慰剂MLD。所有受试者接受3周的每日强化治疗和6个月的维持治疗。随访期为6个月。主要结局是手臂/手部淋巴水肿体积的减少以及肩部/躯干水平淋巴液淤滞的变化。
