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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Breast Carcinoma

Treatments: Procedure: Vascularized Lymph Node Transfer; Procedure: Mammoplasty

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03990610

2018-0528 (Other Identifier)

NCI-2019-03182 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have undergone treatment (mastectomy, axillary lymph node dissection [ALND], radiation and chemotherapy) for breast cancer and are seeking breast reconstruction

Exclusion criteria

• Patients that are known to be pregnant at the time of surgery
• Patients with a known hypersensitivity to indocyanine green (ICG) and/or isosulfan blue (Lymphazurin)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Treatment (vascularized lymph node transfer)

Experimental group

Description:

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

Treatment:

Procedure: Vascularized Lymph Node Transfer

Procedure: Mammoplasty