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

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.

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.

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.

Lead Organization
M D Anderson Cancer Center

Principal Investigator
Mark Schaverien

Primary ID 2018-0127
Secondary IDs NCI-2019-02320
Clinicaltrials.gov ID NCT03941756