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ILR to Prevent BRCL_MCC 23608

NCT07127003 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-04-30

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the effectiveness of Immediate Lymphatic Reconstruction (ILR) in preventing breast cancer-related lymphedema (BCRL) in high-risk patients. It will also assess the safety and quality of life outcomes associated with the procedure. The main questions it aims to answer are:

Does ILR reduce the incidence of BCRL in patients undergoing axillary lymph node dissection (ALND)?

What are the patient-reported outcomes and quality of life differences between those who receive ILR and those who do not?

Participants will be identified as high-risk for developing BCRL through a multidisciplinary tumor board and referred to a specialized clinic for further evaluation. High-risk patients will undergo a series of screening tests, including bioimpedance spectroscopy (BIS), circumferential limb measurements, and infrared 3D perometry.

Participants will be randomly assigned to one of two groups:

Intervention Group (Study Arm A): Undergo ILR during ALND surgery, where preserved lymphatic channels are connected to nearby veins to prevent lymphedema.

Control Group (Study Arm B): Will not receive ILR, but efforts will be made to preserve lymphatic channels during surgery.

Patients will be blinded to their group assignment. Post-surgery, all participants will receive education from a certified lymphatic physical therapist.

At the 2-week postoperative visit, participants will be further randomized into two postoperative monitoring protocols:

BCRL Clinical Pathway: Patients will have regular follow-up visits every three months for two years, including repeat BIS, limb measurements, perometry, and quality of life questionnaires (LYMQOL and ULL-27).

Standard of Care: Patients will be monitored only if they experience BCRL symptoms or after two years from ALND.

The study will compare the outcomes of both groups, with a focus on the incidence of BCRL and patient quality of life, and will benchmark these results against published literature on breast cancer patients.

Conditions

  • Breast Cancer Lymphedema

Interventions

PROCEDURE

Immediate Lymphatic Reconstruction

Preserved lymphatic channels are connected to nearby veins to prevent lymphedema during the axillary lymph node dissection.

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-10-01
Completion
2027-10-01

Countries

  • United States

Study Locations

More Related Trials

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 NCT07127003 on ClinicalTrials.gov