Kappos, Elisabeth A. and Haas, Yvonne and Schulz, Alexandra and Peters, Florian and Savanthrapadian, Shakuntala and Stoffel, Julia and Katapodi, Maria C. and Mucklow, Rosine and Kaiser, Benedict and Haumer, Alexander and Etter, Stephanie and Cattaneo, Marco and Staub, Daniel and Ribi, Karin and Shaw, Jane and Handschin, Tristan M. and Eisenhardt, Steffen and Visconti, Giuseppe and Franceschini, Gianluca and Scardina, Lorenzo and Longo, Benedetto and Vetter, Marcus and Zaman, Khalil and Plock, Jan A. and Scaglioni, Mario and Gonzalez, Eduardo G. and Quildrian, Sergio D. and Felmerer, Gunther and Mehrara, Babak J. and Ayala, Jaume Masia and Pons, Gemma and Kalbermatten, Daniel F. and Sacks, Justin M. and Halle, Martin and Muntean, Maximillian and Taylor, Erin M. and Mani, Maria and Jung, Florian J. and di Summa, Pietro G. and Demiri, Efterpi and Dionyssiou, Dimitris and Groth, Anne K. and Heine, Norbert and Vorstenborsch, Joshua and Isaac, Kathryn and Qiu, Shan Shan and Engels, Patricia E. and Serre, Axelle and Eberhardt, Anna-Lena and Ebner, Sonja and Schwenkglenks, Matthias and Stoel, Yvette and Leo, Cornelia and Horch, Raymund E. and Blondeel, Phillip and Behr, Bjoern and Kneser, Ulrich and Prantl, Lukas and Boll, Daniel T. and Granziera, Cristina and Hemkens, Lars and Lindenblatt, Nicole and Haug, Martin and Schaefer, Dirk J. and Hirche, Christoph and Pusic, Andrea L. and Seidenstuecker, Katrin and Harder, Yves and Weber, Walter (2025) The LYMPH trial: comparing microsurgical with conservative treatment for chronic breast cancer-associated lymphoedema - study protocol of a pragmatic randomised international multicentre superiority trial. BMJ OPEN, 15 (2): e090662. ISSN 2044-6055,
Full text not available from this repository. (Request a copy)Abstract
Introduction Up to one-fifth of breast cancer survivors will develop chronic breast cancer-related lymphoedema (BCRL). To date, complex physical decongestion therapy (CDT) is the gold standard of treatment. However, it is mainly symptomatic and often ineffective in preventing BCRL progression. Lymphovenous anastomosis (LVA) and vascularised lymph node transfer (VLNT) are microsurgical techniques that aim to restore lymphatic drainage. This international randomised trial aims to evaluate advantages of microsurgical interventions plus CDT versus CDT alone for BCRL treatment. Methods and analysis The effectiveness of LVA and/or VLNT in combination with CDT, which may be combined with liposuction, versus CDT alone will be evaluated in routine practice across the globe. Patients with BCRL will be randomly allocated to either surgical or conservative therapy. The primary end point of this trial is the patient-reported quality of life (QoL) outcome 'lymphoedema-specific QoL', which will be assessed 15 months after randomisation. Secondary end points are further patient-reported outcomes (PROs), arm volume measurements, economic evaluations and imaging at different time points. A long-term follow-up will be conducted up to 10 years after randomisation. A total of 280 patients will be recruited in over 20 sites worldwide. Ethics and dissemination This study will be conducted in compliance with the Declaration of Helsinki and the International Council for Harmonisation-Good Clinical Practice (ICH-GCP) E6 guideline. Ethical approval has been obtained by the lead ethics committee 'Ethikkommission Nordwest- und Zentralschweiz' (2023-00733, 22 May 2023). Ethical approval from local authorities will be sought for all participating sites. Regardless of outcomes, the findings will be published in a peer-reviewed medical journal. Metadata detailing the dataset's type, size and content will be made available, along with the full study protocol and case report forms, in public repositories in compliance with the Findability, Accessibility, Interoperability and Reuse principles. Trial registration number NCT05890677.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | QUALITY-OF-LIFE; LONG-TERM OUTCOMES; ARM-LYMPHEDEMA; NODE TRANSFER; RISK-FACTORS; EXTREMITY LYMPHEDEMA; COMPRESSION THERAPY; MANAGEMENT; SURVIVORS; SURGERY; clinical trial; breast tumours; patient reported outcome measures; plastic & reconstructive surgery; randomized controlled trial |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Plastische-, Hand- und Wiederherstellungschirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 24 Mar 2026 08:55 |
| Last Modified: | 24 Mar 2026 08:55 |
| URI: | https://pred.uni-regensburg.de/id/eprint/68063 |
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