NCT03990610

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Mammoplasty	Undergo standard of care breast reconstructive surgery
PROCEDURE	Vascularized Lymph Node Transfer	Undergo vascularized lymph node transfer

Timeline

• Start date: 2019-05-24
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2019-06-19
• Last updated: 2025-10-07

Locations

1 site across 1 country: United States