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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Surgical Intervention
  • Conservative Complex Physical Decongestion Therapy

Treatment groups

280 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Basel, Switzerland

Lead sponsor

Swiss National Science Foundation

Collaborator

Rising Tide Foundation

Collaborator

Krebsforschung Schweiz, Bern, Switzerland

Collaborator