Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer

Overview

This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.

Full Title of Study: “Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy in Patients With Inflammatory Breast Cancer: A Prospective, Randomized Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the protective benefit to performing lymphovenous bypass (LVB) surgery at the time of axillary lymph node dissection (ALND) for patients that are high risk for developing breast-cancer related lymphedema (LE) of the upper extremity.

SECONDARY OBJECTIVES:

I. Compare the medical outcomes for patients receiving LVB surgery with those receiving standard surgery without the intervention.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive indocyanine green intravenously (IV) and undergo lymphangiography, then undergo LVB at the time of ALND.

GROUP II: Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.

After completion of study, patients are followed up at 2 weeks, and then at 6, 12, and 18 months.

Interventions

  • Drug: Indocyanine Green
    • Given IV
  • Procedure: Lymphangiography
    • Undergo lymphangiography
  • Procedure: Lymphovenous Bypass
    • Undergo LVB

Arms, Groups and Cohorts

  • Experimental: Group I (LVB)
    • Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.
  • No Intervention: Group II (no intervention)
    • Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.

Clinical Trial Outcome Measures

Primary Measures

  • Volumetric diagnosis of lymphedema
    • Time Frame: 18 months
    • If the limb volume change, meets the criteria for a diagnosis of lymphedema at any time (5 percent, change), then the patient receives a diagnosis of lymphedema.
  • Incidence of lymphedema
    • Time Frame: 18 months
    • Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients willing to participate.
  • Patients able to complete informed consent.
  • Patients with inflammatory breast cancer, and those with locally advanced non-inflammatory breast cancer that are undergoing ALND and are anticipated to receive radiation therapy.

Exclusion Criteria

  • Patients taking anticoagulants within 7 days prior to surgery.
  • Patients that are known to be pregnant at the time of surgery.
  • Patients are available for follow-up less than 18 months.
  • Patients with known iodine hypersensitivity.
  • Patients with known hypersensitivity to indocyanine green (ICG).
  • Patients with body mass index (BMI) greater than 40.0.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • M.D. Anderson Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mark Schaverien, Principal Investigator, M.D. Anderson Cancer Center
  • Overall Contact(s)
    • Mark Schaverien, 713-794-1247, mvschaverien@mdanderson.org

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