ORIGINAL ARTICLES   

International Angiology 2010 October;29(5):442-53

Copyright © 2010 EDIZIONI MINERVA MEDICA

language: English

Clinical trials needed to evaluate compression therapy in breast cancer related lymphedema (BCRL). Proposals from an expert group

Partsch H. ¹, Stout N. ², Forner-Cordero I. ³, Flour M. ⁴, Moffatt C. ⁵, Szuba A. ^{6, 7}, Milic D. ⁸, Szolnoky G. ⁹, Brorson H. ¹⁰, Abel M. ¹¹, Schuren J. ¹², Schingale F. ¹³, Vignes S. ¹⁴, Piller N. ¹⁵, Döller W. ¹⁶ ✉

¹ Dermatology, Medical University of Vienna, Vienna, Austria 2 Breast Care Department, National Naval Medical Center, Bethesda, MD, USA 3 Specialist in Physical Medicine and Rehabilitation, Valencia, Spain 4 Dermatology, University Hospital KU Leuven, Belgium 5 Glasgow Medical School, Glasgow, UK 6 Department of Internal Medicine, Wroclaw Medical University, Wroclaw, Poland 7 Department of Physiotherapy, Wroclaw School of Physical Education, Wroclaw, Poland 8 Clinic for Vascular Surgery, University Clinical Centre Nis, Nis, Serbia 9 Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary 10Department of Clinical Sciences Malmö, Lund University, Plastic and Reconstructive Surgery, Malmö University Hospital, Malmö, Sweden 11Lohmann & Rauscher, Rengsdorf, Germany 12Medical Markets Laboratory, Neuss, Germany 13Lympho-Opt Clinic, Pommelsbrunn, Germany 14Department of Lymphology, Hôpital Cognacq-Jay, Paris, France 15Department of Surgery, School of Medicine, Flinders Medical Centre, Bedford Park South, Australia 16Center of Lymphology, General Hospital Wolfsberg, Austria

AIM: A mainstay of lymphedema management involves the use of compression therapy. Compression therapy application is variable at different levels of disease severity. Evidence is scant to direct clinicians in best practice regarding compression therapy use. Further, compression clinical trials are fragmented and poorly extrapolable to the greater population. An ideal construct for conducting clinical trials in regards to compression therapy will promote parallel global initiatives based on a standard research agenda. The purpose of this article is to review current evidence in practice regarding compression therapy for BCRL management and based on this evidence, offer an expert consensus recommendation for a research agenda and prescriptive trials. Recommendations herein focus solely on compression interventions.
METHODS: This document represents the proceedings of a session organized by the International Compression Club (ICC) in June 2009 in Ponzano (Veneto, Italy). The purpose of the meeting was to enable a group of experts to discuss the existing evidence for compression treatment in breast cancer related lymphedema (BCRL) concentrating on areas where randomized controlled trials (RCTs) are lacking.
RESULTS: The current body of research suggests efficacy of compression interventions in the treatment and management of lymphedema. However, studies to date have failed to adequately address various forms of compression therapy and their optimal application in BCRL. We offer recommendations for standardized compression research trials for prophylaxis of arm lymphedema and for the management of chronic BCRL. Suggestions are also made regarding; inclusion and exclusion criteria, measurement methodology and additional variables of interest for researchers to capture.
CONCLUSION: This document should inform future research trials in compression therapy and serve as a guide to clinical researchers, industry researchers and lymphologists regarding the strengths, weaknesses and shortcomings of the current literature. By providing this construct for research trials, the authors aim to support evidence-based therapy interventions, promote a cohesive, standardized and informative body of literature to enhance clinical outcomes, improve the quality of future research trials, inform industry innovation and guide policy related to BCRL.