Comparing Microsurgical and Conservative Treatments for Chronic Breast Cancer-Related Lymphedema to Improve Quality of Life

What this Trial Is About

This research aims to evaluate whether lymphatic surgery improves quality of life better than conservative treatment in patients with chronic breast cancer-related lymphedema BCRL. The study focuses on comparing surgical techniques with the current standard conservative therapy to understand which approach provides better long-term benefits. It is a pragmatic, randomized, international multicenter trial seeking to provide scientific evidence on the effectiveness of surgery over conservative care for this condition. Participants will be randomly assigned to one of two groups. The surgical group may receive lymphovenous anastomosis LVA, vascularized lymph node transfer VLNT, or a combination of both, with some possibly also undergoing liposuction depending on local standards. The conservative group will receive complex physical decongestion therapy CDT, which includes manual lymphatic drainage, compression bandages and garments, physical exercises, and skin care. Both treatments are delivered according to usual care practices, with treatment details and frequency documented. Throughout the study, participants will complete quality of life questionnaires at baseline and 15 months after randomization, with further assessments up to 10 years. Researchers will monitor changes in pain, surgical complications, lymphangitic events, arm volume, frequency of lymphatic drainage, patient burden, and economic impact. The study involves long-term follow-up to evaluate outcomes, safety, and treatment effects, with participation lasting up to 10 years.

The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema