NCT05890677Recruiting
The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
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)
Inclusion criteria
• 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.
Exclusion criteria
• 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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- No phase (N/A)
- Study type
- Interventional
- Countries
- Switzerland, Germany, Italy, Austria, United States, Belgium, Brazil, Canada, Greece, Israel, Netherlands, Romania, Spain, Sweden, Taiwan
- Sponsor
- University Hospital, Basel, Switzerland(Other)
- Protocol no.
- 2023-00733; mu21kappos
- Conditions
- Lymphedema, Breast Cancer
- Interventions
- Procedure
Treatments studied
- Surgical Intervention
- Conservative Complex Physical Decongestion Therapy
Collaborators
Swiss National Science Foundation, Rising Tide Foundation, Krebsforschung Schweiz, Bern, Switzerland
Locations · 33
- Basel, SwitzerlandUniversity Hospital BaselRecruiting at this site
- Lausanne, SwitzerlandCentre Hospitalier Universitaire VaudoisRecruiting at this site
- Aarau, SwitzerlandKantonsspital AarauRecruiting at this site
- Geneva, SwitzerlandHôpitaux Universitaires de GenèveRecruiting at this site
- Winterthur, SwitzerlandKantonsspital WinterthurRecruiting at this site
- Zurich, SwitzerlandKlinik für Plastische, Rekonstruktive, Aesthetische und HandchirurgieRecruiting at this site
- Bochum, GermanyBG Universitätsklinikum Bergmannsheil BochumRecruiting at this site
- Düsseldorf, GermanySana Kliniken DüsseldorfRecruiting at this site
- Erlangen, GermanyUniklinikum ErlangenRecruiting at this site
- Essen, GermanyKEM Evang. Kliniken Essen-MitteRecruiting at this site
- Frankfurt, GermanyBG Klinik Frankfurt am MainRecruiting at this site
- Freiburg im Breisgau, GermanyUniversitätsklinikum Freiburg, Klinik für Plastische und HandchirurgieRecruiting at this site
- Ludwigshafen am Rhein, GermanyBG Klinik LudwigshafenRecruiting at this site
- Nuremberg, GermanyKlinikum NürnbergRecruiting at this site
- Regensburg, GermanyCaritas Krankenhaus St. Josef/ Uniklinik RegensburgRecruiting at this site
- Rome, ItalyPoliclinico Tor Vergata: Fondazione PTVRecruiting at this site
- Rome, ItalyPoliclinico Universitario Fondazione Agostino GemelliRecruiting at this site
- Sankt Pölten, AustriaUniversity Clinics St.PöltenRecruiting at this site
- Vienna, AustriaKrankenhaus Göttlicher Heiland GmbHRecruiting at this site
- Boston, United StatesHarvard Medical SchoolRecruiting at this site
- Rochester, United StatesMayo ClinicRecruiting at this site
- St Louis, United StatesWashington University School of Medicine in St. LouisRecruiting at this site
- Brussels, BelgiumBrussels University HospitalRecruiting at this site
- Ghent, BelgiumUniversity of GhentRecruiting at this site
- Montreal, CanadaMcGill University, Royal Victoria HospitalRecruiting at this site
- Vancouver, CanadaUniversity of British Columbia, Gordon and Leslie Diamond Health Care CentreRecruiting at this site
- Thessaloniki, GreecePapageorgiou Hospital of ThessalonikiRecruiting at this site
- Maastricht, NetherlandsMaastricht University Medical CenterRecruiting at this site
- Cluj-Napoca, RomaniaInstitute of Oncology ''Prof. Dr. Ion Chiricuță'' of Cluj-NapocaRecruiting at this site
- Barcelona, SpainHospital de la Santa Creu i Sant PauRecruiting at this site
In total, worldwide, 33 of the 36 sites listed in the registry are recruiting; the other 3 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 22, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 3 more locations
Other identifiers
- 2023 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.