Comparing surgical and conservative treatments for chronic lymphedema after breast cancer
The LYMPH Trial - Comparing Microsurgical With Conservative Treatment of Chronic Breast Cancer Associated Lymphedema: Study Protocol of a Pragmatic Randomized International Multicentre Superiority Trial
This study is testing whether surgery can help improve the quality of life for people with chronic lymphedema after breast cancer compared to just using physical therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 35 sites (New Haven, Connecticut and 34 other locations) |
| Trial ID | NCT05890677 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether lymphatic surgery improves quality of life for patients with chronic breast cancer-related lymphedema compared to conservative treatment alone. Participants will be randomly assigned to receive either surgical intervention or conservative complex physical decongestion therapy, which includes manual lymphatic drainage and compression. The effectiveness of these approaches will be assessed using a specific quality of life questionnaire 15 months after randomization. This multicentric randomized controlled trial seeks to provide evidence for the most effective treatment options for this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of breast cancer and chronic lymphedema persisting for more than three months.
Not a fit: Patients with primary congenital lymphedema or those who have previously undergone surgical treatment for lymphedema on the affected side may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and quality of life for patients suffering from chronic lymphedema after breast cancer.
How similar studies have performed: While conservative treatment is currently the standard, this study is novel as it is the first multicentric randomized controlled trial to compare surgical techniques directly against conservative treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Haven, Connecticut and 34 other locations
- Yale School of Medicine — New Haven, Connecticut, United States (Not_yet_recruiting)
- Harvard Medical School — Boston, Massachusetts, United States (Not_yet_recruiting)
- Washington University School of Medicine in St. Louis — St Louis, Missouri, United States (Recruiting)
- Mayo Clinic — Rochester, New York, United States (Not_yet_recruiting)
- Krankenhaus Göttlicher Heiland GmbH — Vienna, Austria (Not_yet_recruiting)
- Brussels University Hospital — Brussels, Jette, Belgium (Not_yet_recruiting)
- University of Ghent — Ghent, Belgium (Recruiting)
- Hospital Erasto Gaertner — Paraná, Curitiba, Brazil (Not_yet_recruiting)
- McGill University, Royal Victoria Hospital — Montreal, Canada (Recruiting)
- University of British Columbia, Gordon and Leslie Diamond Health Care Centre — Vancouver, Canada (Recruiting)
- BG Universitätsklinikum Bergmannsheil Bochum — Bochum, Germany (Recruiting)
- Sana Kliniken Düsseldorf — Düsseldorf, Germany (Recruiting)
- Uniklinikum Erlangen — Erlangen, Germany (Recruiting)
- KEM Evang. Kliniken Essen-Mitte — Essen, Germany (Recruiting)
- BG Klinik Frankfurt am Main — Frankfurt, Germany (Recruiting)
- Universitätsklinikum Freiburg, Klinik für Plastische und Handchirurgie — Freiburg im Breisgau, Germany (Recruiting)
- BG Klinik Ludwigshafen — Ludwigshafen am Rhein, Germany (Recruiting)
- Klinikum Nürnberg — Nuremberg, Germany (Recruiting)
- Caritas Krankenhaus St. Josef/ Uniklinik Regensburg — Regensburg, Germany (Recruiting)
- Papageorgiou Hospital of Thessaloniki — Thessaloniki, Greece (Recruiting)
- Rambam Health Clinic, ISR — Haifa, Israel (Not_yet_recruiting)
- Policlinico Tor Vergata: Fondazione PTV — Rome, Italy (Not_yet_recruiting)
- Policlinico Universitario Fondazione Agostino Gemelli — Rome, Italy (Recruiting)
- Maastricht University Medical Center — Maastricht, Netherlands (Recruiting)
- Institute of Oncology ''Prof. Dr. Ion Chiricuță'' of Cluj-Napoca — Cluj-Napoca, Romania (Recruiting)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
- Karolinska Institutet, K1 Molekylär medicin och kirurgi — Stockholm, Sweden (Not_yet_recruiting)
- Department of Plastic and Reconstructive Surgery Uppsala University Hospital — Uppsala, Sweden (Recruiting)
- Kantonsspital Aarau — Aarau, Switzerland (Recruiting)
- University Hospital Basel — Basel, Switzerland (Recruiting)
- Hôpitaux Universitaires de Genève — Geneva, Switzerland (Recruiting)
- Centre Hospitalier Universitaire Vaudois — Lausanne, Switzerland (Recruiting)
- Kantonsspital Winterthur — Winterthur, Switzerland (Recruiting)
- Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie — Zurich, Switzerland (Recruiting)
- Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan (Not_yet_recruiting)
Study contacts
- Principal investigator: Elisabeth Kappos, Prof. Dr. — University Hospital, Basel, Switzerland
- Study coordinator: Elisabeth Kappos, Prof. Dr.
- Email: elisabeth.kappos@usb.ch
- Phone: +41 61 328 62 54
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.