RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

Official Title

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

Quick Facts

Study Start:2023-07-14
Study Completion:2036-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05890677

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Written informed consent.
  2. * Patients ≥ 18 years of age.
  3. * Previous diagnosis of breast cancer.
  4. * 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).
  5. * Minimum of 3 months Conservative Complex Physical Decongestion Therapy.
  6. * Ability to complete the QoL questionnaires.
  1. * No indication for lymphatic surgery according to clinical judgment of the treating surgeon (individual reasons will be specifically documented).
  2. * Primary congenital Lymphedema or non-BCRL.
  3. * Previous surgical BCRL treatment.

Contacts and Locations

Study Contact

Elisabeth Kappos, Prof. Dr.
CONTACT
+41 61 328 62 54
elisabeth.kappos@usb.ch

Principal Investigator

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

Study Locations (Sites)

Harvard Medical School
Boston, Massachusetts, 02115
United States
Washington University School of Medicine in St. Louis
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: University Hospital, Basel, Switzerland

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-14
Study Completion Date2036-06

Study Record Updates

Study Start Date2023-07-14
Study Completion Date2036-06

Terms related to this study

Keywords Provided by Researchers

  • lymphatic surgery
  • breast cancer related lymphedema
  • sentinel lymph node biopsy
  • axillary lymph node dissection
  • manual lymphatic drainage
  • conservative complex physical decongestion therapy

Additional Relevant MeSH Terms

  • Lymphedema, Breast Cancer