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The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
Trial Status: active
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)
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.
Additional locations may be listed on ClinicalTrials.gov for NCT05890677.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available
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 bandages and garments, physical exercises and meticulous skin care. It
is, however, too often ineffective to prevent stage progression in curing BCRL and purely
symptomatic. Lymphovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT)
are two surgical techniques that, in contrast to CDT, are able to actually address the
underlying causes and eventually restore the lymphatic drainage. LVA achieves this by
creating numerous bypasses between lymphatic vessels and venules allowing the drainage of
excessive fluid within the subcutaneous tissues into the venous system, while VLNT
usually brings functioning lymph nodes to an area devoid of lymph nodes or with
dysfunctional lymph nodes, thus enabling the spontaneous development of new lymphatic
pathways. Both techniques have shown very promising results with low complication rates
and improved Quality of Life (QoL) for the patients. However, no multicentric randomized
controlled trial (RCT) has yet prospectively evaluated the superiority of these surgical
techniques over CDT alone, limiting patient's access to most effective treatment
available. Requests for cost reimbursement must still be submitted to insurance companies
in most countries and are often rejected, thus delaying surgical treatment and resulting
in prolonged suffering of affected patients. This is untenable seeing as affected
patients suffer from a heavy physical, psychological and financial burden. This
pragmatic, randomized, multicenter trial aims to establish a solid scientific basis
assessing the superiority of surgical treatment over CDT alone.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity Hospital, Basel, Switzerland