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

Not Applicable

Active, not recruiting

• Conditions: Breast Carcinoma
• Interventions: Procedure: Mammoplasty; Procedure: Vascularized Lymph Node Transfer

• Registration Number: NCT03990610
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Study Timeline

• Study Start: 2019-05-24
• Study First Submitted: 2019-06-17
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (vascularized lymph node transfer)	Mammoplasty	Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.
Treatment (vascularized lymph node transfer)	Vascularized Lymph Node Transfer	Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.

Primary Outcome Measures

Name	Time	Method
Incidence rate of lymphedema development	At 12 months after surgery	Summary statistics such as means, standard deviations, median and range for continuous variables, and frequencies and percentages for categorical variables will be reported. The rate of lymphedema and its 95% exact confidence interval will be estimated.
Time to lymphedema development	Up to 2 years	Will be estimated by the Kaplan-Meier method.

Secondary Outcome Measures

Name	Time	Method
Incidence rate of lymphedema development	Up to 2 years	The incidence of lymphedema between patients who undergo vascularized lymph node transfer (VLNT) and historical cohorts who do not will be compared. The inverse probability of treatment weighting using the propensity scores will be applied to estimate the effect of VLNT.
Complications of prophylactic VLNT	Within 30 days after surgery	Overall complications will include infections, dehiscence, hematoma, seroma and flap compromises. The 95% exact confidence interval will be estimated.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States