The LYMPH trial : comparing microsurgical with conservative treatment for chronic breast cancer-associated lymphoedema - study protocol of a pragmatic randomised international multicentre superiority trial
Kappos, E.A. (University of Basel)
Haas, Y. (University of Basel)
Schulz, A. (Department of Clinical Research. University Hospital Basel)
Peters, F. (Department of Clinical Research. University Hospital Basel)
Savanthrapadian, S. (Department of Clinical Research. University Hospital Basel)
Stoffel, J. (University of Basel)
Katapodi, M.C. (Department of Clinical Research. Founding Member Patient Advocacy Group Oncoplastic Breast Consortium. University Hospital Basel)
Mucklow, R. (Patient Advocacy Group. Oncoplastic Breast Consortium)
Kaiser, B. (Department of Plastic. Reconstructive. Aesthetic and Handsurgery. University Hospital Basel)
Haumer, A. (Department of Plastic. Reconstructive. Aesthetic and Handsurgery. University Hospital Basel)
Etter, S. (Department of Plastic. Reconstructive. Aesthetic and Handsurgery. University Hospital Basel)
Cattaneo, M. (Department of Clinical Research. University Hospital Basel)
Staub, D. (Department of Angiology. University Hospital Basel)
Ribi, K. (Quality of Life Office. International Breast Cancer Study Group. A Division of ETOP IBCSG Partners Foundation. Careum)
Shaw, J. (Patient Advocacy Group. Oncoplastic Breast Consortium)
Handschin, T.M. (University of Basel)
Eisenhardt, S. (Department of Plastic and Hand Surgery. University Hospital Freiburg)
Visconti, G. (Department of Woman and Child Health and Public Health. Division of Plastic Surgery. Fondazione Policlinico Universitario Agostino Gemelli IRCCS)
Franceschini, G. (Department of Woman. Child Health and Public Health. Division of Breast Surgery. Fondazione Policlinico Universitario Agostino Gemelli IRCCS)
Scardina, L. (Department of Woman. Child Health and Public Health. Division of Breast Surgery. Fondazione Policlinico Universitario Agostino Gemelli IRCCS)
Longo, B. (Department of Plastic and Reconstructive Surgery. University of Rome Tor Vergata)
Vetter, M. (Department of Oncology. Cantonal Hospital Basel-Landschaft)
Zaman, K. (Department of Medical Oncology. Lausanne University Hospital)
Plock, J.A. (Department of Plastic Surgery and Hand Surgery. Cantonal Hospital Aarau)
Scaglioni, M. (Center for Plastic Surgery. Center for Breast Cancer Surgery. Klinik Pyramide am See)
Gonzalez, E.G. (Division of Oncoplastic Surgery. Buenos Aires British Hospital. University of Buenos Aires. Instituto de Oncología Angel H Roffo)
Quildrian, S.D. (Division of Oncoplastic Surgery. Buenos Aires British Hospital. University of Buenos Aires. Instituto de Oncología Angel H Roffo)
Felmerer, G. (Department of Trauma Surgery. Orthopedic Surgery and Plastic Surgery. University Medical Center Göttingen)
Mehrara, B.J. (Department of Plastic and Reconstructive Surgery. Memorial Sloan Kettering Cancer Center)
Masià, Jaume (Institut de Recerca Sant Pau)
Pons, Gemma (Institut de Recerca Sant Pau)
Kalbermatten, D.F. (Department of Plastic. Reconstructive. and Aesthetic Surgery. Geneva University Hospitals)
Sacks, J.M. (Division of Plastic and Reconstructive Surgery. Washington University School of Medicine in Saint Louis)
Halle, M. (Department of Reconstructive Plastic Surgery. Karolinska University Hospital)
Muntean, M.V. (Department of Plastic Surgery. Institute of Oncology. University of Medicine and Pharmacy "Iuliu Hatieganu")
Taylor, E.M. (Division of Plastic and Reconstructive Surgery. Department of Surgery. Brigham and Women's Hospital. Harvard Medical School)
Mani, M. (Department of Plastic and Maxillofacial Surgery. Uppsala University Hospital)
Jung, F.J. (Department of Plastic and Hand Surgery. Cantonal Hospital Winterthur)
Di Summa, P.G. (Department of Plastic and Hand Surgery. CHUV)
Demiri, E. (Department of Plastic Surgery. Aristotle University of Thessaloniki)
Dionyssiou, D. (Department of Plastic Surgery. Aristotle University of Thessaloniki)
Groth, A.K. (Department of Plastic Surgery. Hospital Erasto Gaertner)
Heine, N. (Department of Plastic Surgery. Caritas Hospital St. Josef)
Vorstenborsch, J. (Division of Plastic Surgery. McGill University)
Isaac, K.V. (Division of Plastic Surgery. The University of British Columbia)
Qiu, S.S. (Department of Plastic. Reconstructive and Hand Surgery. Maastricht University Medical Centre)
Engels, P.E. (Department of Plastic. Reconstructive. and Aesthetic Surgery. Geneva University Hospitals)
Serre, A. (Department of Plastic. Reconstructive. and Aesthetic Surgery. Geneva University Hospitals)
Eberhardt, A.L. (Department of Radiation Oncology. University Hospital Basel)
Ebner, S. (Department of Obstetrics and Gynecology. Cantonal Hospital Basel-Landschaft)
Schwenkglenks, M. (Institute of Pharmaceutical Medicine (ECPM). University of Basel)
Stoel, Y. (Institute of Therapies and Rehabilitation. Division of Physiotherapy. Cantonal Hospital Winterthur)
Leo, C. (Breast Center. Kantonsspital Baden AG)
Horch, R.E. (Department of Plastic and Hand Surgery. Erlangen University Hospital)
Blondeel, P. (Department of Plastic and Reconstructive Surgery. University Hospital Ghent)
Behr, B. (Department of Plastic. Reconstructive and Aesthetic Surgery. KEM Kliniken Essen-Mitte)
Kneser, U. (Department of Hand. Plastic and Reconstructive Surgery. Burn Center. University Hospital Heidelberg. BG Klinik Ludwigshafen)
Prantl, L. (Department of Plastic Surgery. University Hospital Regensburg)
Boll, D.T. (Department of Radiology and Nuclear Medicine. University Hospital Basel)
Granziera, C. (Neurology Clinic and Policlinic. Departments of Head. Spine and Neuromedicine. Biomedicine and Clinical Research. University Hospital Basel)
Hemkens, L. (Meta-Research Innovation Center Berlin (METRIC-B). Berlin Institute of Health)
Lindenblatt, N. (Department of Plastic and Hand Surgery. University Hospital Zurich)
Haug, M. (University of Basel)
Schaefer, D.J. (University of Basel)
Hirche, C. (Department of Plastic. Hand and Reconstructive Microsurgery. Hand Trauma and Replantation Centre. BG Unfallklinik Frankfurt am Main)
Pusic, A.L. (Division of Plastic and Reconstructive Surgery. Department of Surgery. Brigham and Women's Hospital. Harvard Medical School)
Seidenstuecker, K. (Department of Plastic Surgery. Sana Kliniken Düsseldorf GmbH)
Harder, Y. (Faculty of Biology and Medicine. Universite de Lausanne)
Weber, W. (Breast Center. University Hospital Basel)
Universitat Autònoma de Barcelona

Data:	2025
Resum:	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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Breast tumours ; Clinical trial ; Patient reported outcome measures ; Plastic & reconstructive surgery ; Randomized controlled trial
Publicat a:	BMJ open, Vol. 15 Núm. 2 (17 2025) , p. e090662, ISSN 2044-6055

DOI: 10.1136/bmjopen-2024-090662
PMID: 39961719

15 p, 899.3 KB

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