ILR to Prevent BRCL_MCC 23608

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.