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NCT Number: NCT03990610

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mammoplasty

Procedure

Undergo standard of care breast reconstructive surgery

Other names: Breast Reconstruction

Vascularized Lymph Node Transfer

Procedure

Undergo vascularized lymph node transfer

Other names: VLNT

Primary outcomes

  1. Incidence rate of lymphedema development

    Time frame: 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.

  2. Time to lymphedema development

    Time frame: Up to 2 years

    Will be estimated by the Kaplan-Meier method.

Secondary outcomes

  1. Incidence rate of lymphedema development

    Time frame: 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.

  2. Complications of prophylactic VLNT

    Time frame: Within 30 days after surgery

    Overall complications will include infections, dehiscence, hematoma, seroma and flap compromises. The 95% exact confidence interval will be estimated.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Jun 19, 2019
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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