Status:

RECRUITING

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

Lead Sponsor:

University Hospital, Basel, Switzerland

Collaborating Sponsors:

Swiss National Science Foundation

Rising Tide Foundation

Conditions:

Lymphedema, Breast Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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)) ...

Detailed Description

To date, conservative complex physical decongestion therapy (CDT) is the gold standard for BCRL (breast cancer related lymphedema) and includes manual lymphatic drainage, local compression with bandag...

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.

Key Trial Info

Start Date :

July 14 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2036

Estimated Enrollment :

280 Patients enrolled

Trial Details

Trial ID

NCT05890677

Start Date

July 14 2023

End Date

June 1 2036

Last Update

November 14 2025

Active Locations (35)

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Page 1 of 9 (35 locations)

1

Yale School of Medicine

New Haven, Connecticut, United States, 06510

2

Harvard Medical School

Boston, Massachusetts, United States, 02115

3

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States, 63110

4

Mayo Clinic

Rochester, New York, United States, 55905