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The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
The LYMPH Trial - Comparing Microsurgical With Conservative Treatment of Chronic Breast Cancer Associated Lymphedema: Study Protocol of a Pragmatic Randomized International Multicentre Superiority Trial
Who can join
Ages 18 and older · All sexes
Full eligibility 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.
About the 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)
What is being tested
- Surgical Intervention (procedure)
- Conservative Complex Physical Decongestion Therapy (procedure)
Sponsor: University Hospital, Basel, Switzerland · Participants: 280 · Started: Jul 14, 2023
Contact the study team
- Elisabeth Kappos, Prof. Dr. · Phone: +41 61 328 62 54
Official record on ClinicalTrials.gov — NCT05890677
Locations in the U.S.
| Connecticut | Yale School of Medicine, New Haven (Not yet recruiting) |
| Massachusetts | Harvard Medical School, Boston |
| Missouri | Washington University School of Medicine in St. Louis, St Louis |
| New York | Mayo Clinic, Rochester (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.