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The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema

Recruiting

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

Sponsor: University Hospital, Basel, Switzerland · Participants: 280 · Started: Jul 14, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05890677

Locations in the U.S.

ConnecticutYale School of Medicine, New Haven (Not yet recruiting)
MassachusettsHarvard Medical School, Boston
MissouriWashington University School of Medicine in St. Louis, St Louis
New YorkMayo 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.