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The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
Sponsor: University Hospital, Basel, Switzerland
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)
Official title: The LYMPH Trial - Comparing Microsurgical With Conservative Treatment of Chronic Breast Cancer Associated Lymphedema: Study Protocol of a Pragmatic Randomized International Multicentre Superiority Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2023-07-14
Completion Date
2036-06
Last Updated
2025-11-14
Healthy Volunteers
No
Conditions
Interventions
Surgical Intervention
LVA (Lymphovenous Anastomosis) and VLNT (Vascularised Lymph Node Transfer) are two advanced microsurgical techniques that are increasingly implemented in clinical practice in specialized centers and that are already carried out after health insurance application according to local standard of care. They have been studied in their respective mode of action as well as in their effectiveness in treating chronic BCRL (Breast Cancer-Related Lymphedema) in a multitude of mostly observational and single center studies with highly encouraging results. Patients in the interventional arm A will receive surgery with one of the two approaches or a combination of both, in a one or two-stage method, at the discretion of the treating surgeon. Depending on local standards one or both of the above might be combined with liposuction to the affected arm in a one or two-stage approach as well.
Conservative Complex Physical Decongestion Therapy
Patients randomized to the control arm will receive CDT (Conservative Complex Physical Decongestion Therapy), which currently is considered as the best available standard of care. For this, patients will be referred to one of the dedicated LE (physical/skin) therapy clinics, if not already treated by one, according to their place of residence for continuation of standard conservative therapy. Recommendations to the procedures and treatment frequency of the conservative therapy will be made, but CDT will be done at the discretion of the treating physiotherapist.
Locations (35)
Yale School of Medicine
New Haven, Connecticut, United States
Harvard Medical School
Boston, Massachusetts, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Mayo Clinic
Rochester, New York, United States
Krankenhaus Göttlicher Heiland GmbH
Vienna, Austria
Brussels University Hospital
Brussels, Jette, Belgium
University of Ghent
Ghent, 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
BG Universitätsklinikum Bergmannsheil Bochum
Bochum, Germany
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
BG Klinik Ludwigshafen
Ludwigshafen am Rhein, Germany
Klinikum Nürnberg
Nuremberg, Germany
Caritas Krankenhaus St. Josef/ Uniklinik Regensburg
Regensburg, Germany
Papageorgiou Hospital of Thessaloniki
Thessaloniki, Greece
Rambam Health Clinic, ISR
Haifa, Israel
Policlinico Tor Vergata: Fondazione PTV
Rome, Italy
Policlinico Universitario Fondazione Agostino Gemelli
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
Kantonsspital Aarau
Aarau, Switzerland
University Hospital Basel
Basel, Switzerland
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland
Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie
Zurich, Switzerland
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan