An Investigational Surgical Procedure (Vascularized Lymph Node Transfer) in Reducing the Risk of Lymphedema in Patients With Breast Cancer Undergoing Breast Reconstruction

Breast Carcinoma Clinical Trial

Official title: Assessment of Outcomes Following Prophylactic Lymph Node Transfer in Patients Undergoing Autologous Breast Reconstruction

Status Active, not recruiting

Clinical Trial Summary

This trial studies how an investigational surgical procedure called vascularized lymph node transfer works in lowering the risk of arm swelling (lymphedema) in patients with breast cancer undergoing breast reconstruction. Patients who undergo breast reconstruction are often at high risk of developing lymphedema. Vascularized lymph node transfer involves transferring lymph nodes from an unaffected area of the body to replace those removed as part of treatment, which may lower the risk of lymphedema after breast reconstruction.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. Determine incidence of patients who develop lymphedema following autologous breast reconstruction.

SECONDARY OBJECTIVES:

I. Determine the overall complications of prophylactic vascularized lymph node transfers.

II. Compare the incidence of patients who develop lymphedema following autologous breast reconstruction among patients who had prophylactic lymph node transfer and a historical cohort who did not have prophylactic lymph node transfer.

OUTLINE:

Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.

After completion of study, patients are followed up for 3 weeks, at 3 and 6 months, and then at 1 and 2 years. ;

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

• NCT number: NCT03990610
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 24, 2019
• Completion date: April 30, 2026