The LYMPH Trial - Surgical Versus Conservative Complex Physical Decongestion Therapy for Chronic Breast Cancer-Related Lymphedema

Description

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)

Conditions

Lymphedema, Breast Cancer

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Study Overview

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Study Details

Study overview

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)

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

The LYMPH Trial - Surgical Versus Conservative Complex Physical Decongestion Therapy for Chronic Breast Cancer-Related Lymphedema

Condition
Lymphedema, Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Boston

Harvard Medical School, Boston, Massachusetts, United States, 02115

Saint Louis

Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Written informed consent.
  • * Patients ≥ 18 years of age.
  • * Previous diagnosis of breast cancer.
  • * Clinical diagnosis of chronic Breast Cancer-Related Lymphedema (BCRL) as defined by the international society of lymphology (inter-limb difference of \>10% in volume or excess volume between the affected and non-affected limbs present for more than 3 months).
  • * Minimum of 3 months Conservative Complex Physical Decongestion Therapy.
  • * Ability to complete the QoL questionnaires.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University Hospital, Basel, Switzerland,

Elisabeth Kappos, Prof. Dr., PRINCIPAL_INVESTIGATOR, University Hospital, Basel, Switzerland

Study Record Dates

2036-06