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

RECRUITINGN/ASponsored by University Hospital, Basel, Switzerland
Actively Recruiting
PhaseN/A
SponsorUniversity Hospital, Basel, Switzerland
Started2023-07-14
Est. completion2027-09
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites
View on ClinicalTrials.gov →

NCT05890677

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)) 15 months after randomization (and therefore about one year after surgery) compared to conservative treatment only for patients with chronic lymphedema (LE)

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions3

Breast CancerCancerLymphedema, Breast Cancer

Locations4 sites

Connecticut

1 site
Yale School of Medicine
New Haven, Connecticut, 06510
Siba Haykal, MD, PhD.

Massachusetts

1 site
Harvard Medical School
Boston, Massachusetts, 02115
Andrea Pusic, Prof. Dr. med.+16 17 732 53 61apusic@bwh.harvard.edu

Missouri

1 site
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
Justin M. Sacks, Prof. Dr.314-454-4894jmsacks@wustl.edu

New York

1 site
Mayo Clinic
Rochester, New York, 55905
Vahe Fahrradyan, MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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