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

Recruiting now · Not applicable

Conditions studied: Lymphedema, Breast Cancer

In brief

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)

Key facts

Study ID

NCT05890677

Run by

University Hospital, Basel, Switzerland

People needed

280

Starts

2023-07-14

Expected to finish

2036-06-01

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent.
• Patients ≥ 18 years of age.
• Former diagnosis of breast cancer.
• Clinical diagnosis of chronic Breast Cancer-Related Lymphedema (BCRL) (persisting for more than 3 months) classified as ≥ Stage 1, according to ISL.
• Minimum of 3 months Conservative Complex Physical Decongestion Therapy.
• Ability to complete the QoL questionnaires.
• Willingness to undergo surgery.

You may not qualify if…

• No indication for lymphatic surgery according to clinical judgment of the treating surgeon (individual reasons will be specifically documented).
• Primary congenital Lymphedema or non-BCRL.
• Previous surgical BCRL treatment on the side intended for intervention.

Where it is running

• University Hospital Basel — Basel, Basel, Switzerland (enrolling)
• Centre Hospitalier Universitaire Vaudois — Lausanne, Lausanne, Switzerland (enrolling)
• Kantonsspital Aarau — Aarau, Switzerland (enrolling)
• Hôpitaux Universitaires de Genève — Geneva, Switzerland (enrolling)
• Kantonsspital Winterthur — Winterthur, Switzerland (enrolling)
• Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie — Zurich, Switzerland (enrolling)
• Brussels University Hospital — Brussels, Jette, Belgium (enrolling)
• University of Ghent — Ghent, Belgium (enrolling)
• Washington University School of Medicine in St. Louis — St Louis, Missouri, United States (enrolling)
• McGill University, Royal Victoria Hospital — Montreal, Canada (enrolling)
• University of British Columbia, Gordon and Leslie Diamond Health Care Centre — Vancouver, Canada (enrolling)
• BG Universitätsklinikum Bergmannsheil Bochum — Bochum, Germany (enrolling)
• Sana Kliniken Düsseldorf — Düsseldorf, Germany (enrolling)
• Uniklinikum Erlangen — Erlangen, Germany (enrolling)
• KEM Evang. Kliniken Essen-Mitte — Essen, Germany (enrolling)
• BG Klinik Frankfurt am Main — Frankfurt, Germany (enrolling)
• Universitätsklinikum Freiburg, Klinik für Plastische und Handchirurgie — Freiburg im Breisgau, Germany (enrolling)
• BG Klinik Ludwigshafen — Ludwigshafen am Rhein, Germany (enrolling)
• Klinikum Nürnberg — Nuremberg, Germany (enrolling)
• Caritas Krankenhaus St. Josef/ Uniklinik Regensburg — Regensburg, Germany (enrolling)
• Papageorgiou Hospital of Thessaloniki — Thessaloniki, Greece (enrolling)
• Harvard Medical School — Boston, Massachusetts, United States (enrolling)
• Policlinico Tor Vergata: Fondazione PTV — Rome, Italy (enrolling)
• Policlinico Universitario Fondazione Agostino Gemelli — Rome, Italy (enrolling)
• Maastricht University Medical Center — Maastricht, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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