Recruiting
The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
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)
ClinicalTrials.gov IDNCT05890677
PhaseNA
Enrollment280
SponsorUniversity Hospital, Basel, Switzerland
Age18 Years
SexALL
Conditions studied
Lymphedema, Breast Cancer
About this study
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)
Interventions
- Procedure: 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.
- Procedure: 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.
Primary outcomes
- Change in Quality of Life Questionnaire (Lymph-ICF-UL) (two time assessment at baseline and 15 month after randomization)
Eligibility information
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.
Study locations
- Yale School of Medicine, New Haven, Connecticut 06510 United States
- Harvard Medical School, Boston, Massachusetts 02115 United States
- Washington University School of Medicine in St. Louis, St Louis, Missouri 63110 United States
- Mayo Clinic, Rochester, New York 55905 United States
- University Clinics St.Pölten, Sankt Pölten, Lower Austria Austria
- Krankenhaus Göttlicher Heiland GmbH, Vienna, State of Vienna A-1170 Austria
- Brussels University Hospital, Brussels, Jette 1090 Belgium
- University of Ghent, Ghent, 9000 Belgium
- Hospital Erasto Gaertner, Paraná, Curitiba 80730-001 Brazil
- McGill University, Royal Victoria Hospital, Montreal, QC H4A 3J1 Canada
Showing 10 of 36 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.