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LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

NCT05366699 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-12-29

No results posted yet for this study

Summary

Lymphedema is a chronic, progressive, and debilitating condition that occurs with disruption or obstruction of the lymphatic system, which commonly occurs a result of breast cancer therapy. The purpose of this study is to determine if the use of a low risk lymphatic reconstruction procedure at the time of axillary lymph node dissection will reduce the risk of developing lymphedema.

Additionally, to determine if this procedure improves objective outcomes of lymphedema and patient quality of life

Conditions

  • Lymphedema, Breast Cancer
  • Lymphedema

Interventions

PROCEDURE

axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)

lymphatic reconstruction where the cut lymphatic vessels are reconstructed by anastamosing to the veins

PROCEDURE

Axillary lymphadenetomy alone

oncologic axillary lymphadenectomy

PROCEDURE

axillary lymphadenectomy with soft tissue reinforcement

axillary lymphadenectomy with soft tissue reinforcement(STR)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-10
Primary Completion
2026-06-01
Completion
2030-06-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05366699 on ClinicalTrials.gov