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Brief Title: The LYMPH Trial - Surgical Versus Conservative Complex Physical Decongestion Therapy for Chronic Breast Cancer-Related Lymphedema
Official Title: The LYMPH Trial - Surgical Versus Conservative Complex Physical Decongestion Therapy for Chronic Breast Cancer-Related Lymphedema: A Pragmatic, Randomized, Multicenter Superiority Trial
Study ID: NCT05890677
Brief Summary: The aim of this study is to test whether lymphatic surgery provides better QoL (assessed with the Lymph-ICF-UL, (Lymphedema Functioning Disability and health questionnaire for upper limb lymphedema)) 15 months after randomization (and therefore about one year after surgery) compared to conservative treatment only for patients with chronic lymphedema (LE)
Detailed Description: To date, conservative complex physical decongestion therapy (CDT) is the gold standard for BCRL (breast cancer related lymphedema) and includes manual lymphatic drainage, local compression with bandages and garments, physical exercises and meticulous skin care. It is, however, too often ineffective to prevent stage progression in curing BCRL and purely symptomatic. Lymphovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT) are two surgical techniques that, in contrast to CDT, are able to actually address the underlying causes and eventually restore the lymphatic drainage. LVA achieves this by creating numerous bypasses between lymphatic vessels and venules allowing the drainage of excessive fluid within the subcutaneous tissues into the venous system, while VLNT usually brings functioning lymph nodes to an area devoid of lymph nodes or with dysfunctional lymph nodes, thus enabling the spontaneous development of new lymphatic pathways. Both techniques have shown very promising results with low complication rates and improved Quality of Life (QoL) for the patients. However, no multicentric randomized controlled trial (RCT) has yet prospectively evaluated the superiority of these surgical techniques over CDT alone, limiting patient's access to most effective treatment available. Requests for cost reimbursement must still be submitted to insurance companies in most countries and are often rejected, thus delaying surgical treatment and resulting in prolonged suffering of affected patients. This is untenable seeing as affected patients suffer from a heavy physical, psychological and financial burden. This pragmatic, randomized, multicenter trial aims to establish a solid scientific basis assessing the superiority of surgical treatment over CDT alone.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Harvard Medical School, Boston, Massachusetts, United States
Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States
Universidad de Buenos Aires, Instituto de Oncología Ángel H. Roffo, Buenos Aires, , Argentina
Klinikum Klagenfurt, Klagenfurt, , Austria
University of Ghent, Gent, , Belgium
Hospital Erasto Gaertner, Paraná, Curitiba, Brazil
McGill University, Royal Victoria Hospital, Montreal, , Canada
University of British Columbia, Gordon and Leslie Diamond Health Care Centre, Vancouver, , Canada
Sana Kliniken Düsseldorf, Düsseldorf, , Germany
Uniklinikum Erlangen, Erlangen, , Germany
KEM Evang. Kliniken Essen-Mitte, Essen, , Germany
BG Klinik Frankfurt am Main, Frankfurt, , Germany
Universitätsklinikum Freiburg, Klinik für Plastische und Handchirurgie, Freiburg im Breisgau, , Germany
Universitätsklinikum Göttingen, Göttingen, , Germany
BG Klinik Ludwigshafen, Ludwigshafen am Rhein, , Germany
Caritas Krankenhaus St. Josef/ Uniklinik Regensburg, Regensburg, , Germany
Papageorgiou Hospital of Thessaloniki, Thessaloníki, , Greece
Plastic and Reconstructive Surgery at Department of Surgical Science, Rome, , Italy
Policlinic Gemelli, Operational Unit of Plastic Surgery, Rome, , Italy
Maastricht University Medical Center, Maastricht, , Netherlands
Institute of Oncology ''Prof. Dr. Ion Chiricuță'' of Cluj-Napoca, Cluj-Napoca, , Romania
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Karolinska Institutet, K1 Molekylär medicin och kirurgi, Stockholm, , Sweden
Department of Plastic and Reconstructive Surgery Uppsala University Hospital, Uppsala, , Sweden
Ospedale Regionale di Lugano, Viganello, Lugano, Switzerland
Kantonsspital Aarau, Aarau, , Switzerland
University Hospital Basel, Basel, , Switzerland
Hôpitaux Universitaires de Genève, Genève, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie, Zürich, , Switzerland
Name: Elisabeth Kappos, PD Dr. med.
Affiliation: University Hospital, Basel, Switzerland
Role: PRINCIPAL_INVESTIGATOR