The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
Recruiting · NCT05890677 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Basel, Switzerland
View the official record on ClinicalTrials.gov →Interventions studied
Conservative Complex Physical Decongestion TherapySurgical Intervention
What this trial is about
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)
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
36 locations listed across 4 US states.
- 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
- Kantonsspital Aarau - Aarau, Switzerland
- Hospital de la Santa Creu i Sant Pau - Barcelona, Spain
- BG Universitätsklinikum Bergmannsheil Bochum - Bochum, Germany
- Institute of Oncology ''Prof. Dr. Ion Chiricuță'' of Cluj-Napoca - Cluj-Napoca, Romania
- 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
- Hôpitaux Universitaires de Genève - Geneva, Switzerland
- University of Ghent - Ghent, Belgium
- Rambam Health Clinic, ISR - Haifa, Israel
- BG Klinik Ludwigshafen - Ludwigshafen am Rhein, Germany
- Maastricht University Medical Center - Maastricht, Netherlands
- McGill University, Royal Victoria Hospital - Montreal, Canada
- Klinikum Nürnberg - Nuremberg, Germany
- Caritas Krankenhaus St. Josef/ Uniklinik Regensburg - Regensburg, Germany
- Policlinico Tor Vergata: Fondazione PTV - Rome, Italy
- Policlinico Universitario Fondazione Agostino Gemelli - Rome, Italy
- Karolinska Institutet, K1 Molekylär medicin och kirurgi - Stockholm, Sweden
- Papageorgiou Hospital of Thessaloniki - Thessaloniki, Greece
- Department of Plastic and Reconstructive Surgery Uppsala University Hospital - Uppsala, Sweden
- University of British Columbia, Gordon and Leslie Diamond Health Care Centre - Vancouver, Canada
- Kantonsspital Winterthur - Winterthur, Switzerland
- Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie - Zurich, Switzerland
- University Hospital Basel - Basel, Basel, Switzerland
- Hospital Erasto Gaertner - Paraná, Curitiba, Brazil
- Brussels University Hospital - Brussels, Jette, Belgium
- Centre Hospitalier Universitaire Vaudois - Lausanne, Lausanne, Switzerland
- University Clinics St.Pölten - Sankt Pölten, Lower Austria, Austria
- Krankenhaus Göttlicher Heiland GmbH - Vienna, State of Vienna, Austria
- Kaohsiung Chang Gung Memorial Hospital - Kaohsiung City, Taiwan, Taiwan