The LYMPH Trial: Microsurgical vs. Conservative Treatment for Breast Cancer-Related Lymphedema

This study, called The LYMPH Trial, is looking at the best way to treat chronic lymphedema (swelling caused by fluid buildup) in the arm after breast cancer. It compares two types of surgery, LVA (Lymphovenous Anastomosis) and VLNT (Vascularised Lymph Node Transfer), with the current standard treatment, which is called Conservative Complex Physical Decongestion Therapy (CDT). The study wants to see if surgery improves your quality of life more than CDT after about a year. You might be able to join if you are 18 or older, have been diagnosed with breast cancer, have chronic lymphedema (Stage 1 or higher) for at least three months, and have already tried CDT for at least three months. The study aims to enroll 280 participants, but its current status is unclear.

Study design
This is an interventional study comparing surgical treatments to standard physical therapy. It plans to enroll 280 participants.
What's involved
Participants will complete quality of life questionnaires at the start of the study and again 15 months after being assigned to a treatment group.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 15 months after randomization to assess their quality of life.

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NCT05890677

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

Recruiting
NAAges 18+InterventionalTreatment
University Hospital, Basel, Switzerland
~280 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Surgical InterventionConservative Complex Physical Decongestion Therapy

At a glance

Recruiting sites
29 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Quality of Life Questionnaire (Lymph-ICF-UL)
Measured over two time assessment at baseline and 15 month after randomization
Lymphedema, Breast Cancer
36 sites across 22 states
Germany9
Switzerland4
Canada2
Italy2
Sweden2
Connecticut1
Massachusetts1
Missouri1
  • Elisabeth Kappos, Prof. Dr. · PRINCIPAL_INVESTIGATOR · University Hospital, Basel, Switzerland

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Eligibility criteria

Inclusion

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

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.
  • Change in Quality of Life Questionnaire (Lymph-ICF-UL)two time assessment at baseline and 15 month after randomization

    The LYMPH-ICF-UL-Questionnaire (Lymphedema Functioning Disability and health questionnaire for upper limb lymphedema) is a widely used, rigorously developed, and validated patient-reported outcome (PRO) instrument for chronic breast cancer-related lymphedema. It assesses the impairments in function, activity limitations and participation restrictions of patients with upper limb lymphedema (LE). Consisting of 29 items (questions) across five different domains, each item is scored on a VAS (visual analog scale) ranging from 0 to 10. The total score on the LYMPH-ICF is equal to the sum of the item scores divided by the total number of answered items. A higher score on the Lymph-ICF indicates a greater impact on the functioning in daily life related to upper limb LE. This questionnaire helps determine if lymphatic surgery improves quality of life and patient satisfaction compared to conservative therapy.