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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Melanoma; Anatomic Stage III Breast Cancer AJCC v8; Locally Advanced Breast Carcinoma; Breast Inflammatory Carcinoma

Treatments: Procedure: Lymphangiography; Drug: Indocyanine Green; Procedure: Lymphovenous Bypass

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03941756

P30CA016672 (U.S. NIH Grant/Contract)

2018-0127 (Other Identifier)

NCI-2019-02320 (Registry Identifier)

Details and patient eligibility

About

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 or melanoma. 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 description

PRIMARY OBJECTIVES:

I. To evaluate the protective benefit to performing standard of care lymphovenous bypass (LVB) surgery at the time of standard of care 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 that received the LVB surgery with those receiving standard surgery in whom the intervention could not be performed.

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.

Enrollment: 252 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients greater than or equal to 18 years of age.

• Patients willing to participate.

• Patients able to complete informed consent.

• Patients will be eligible for inclusion if they fall into one for two groups:

  • 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
  • Or: Patients with a diagnosis of melanoma (including unknown primary) that will undergo ALND will also be eligible for inclusion in the study as a comparator group.

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 or do not undergo measurements within the scheduled period.
• Patients with body mass index (BMI) greater than 50.0.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 2 patient groups

Group I (LVB)

Experimental group

Description:

Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.

Treatment:

Procedure: Lymphovenous Bypass

Procedure: Lymphangiography

Drug: Indocyanine Green

Group II (no intervention)

No Intervention group

Description:

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