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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Inflammatory Breast Carcinoma, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8

Intervention / Treatment
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* Drug: Indocyanine Green
* Procedure: Lymphangiography
* Procedure: Lymphovenous Bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients greater than or equal to 18 years of age. 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 or do not undergo measurements within the scheduled period. Patients with BMI greater than 50.0.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (LVB)<br>Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND. | Drug: Indocyanine Green<br>* Given IV<br>* Other names: ICG;Procedure: Lymphangiography<br>* Undergo lymphangiography<br>* Other names: Lymphography;Procedure: Lymphovenous Bypass<br>* Undergo LVB<br>* Other names: Lymphovenous Anastomosis;|
| No Intervention: Group II (no intervention)<br>Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volumetric diagnosis of lymphedema | 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. | 18 months | 
| Incidence of lymphedema | Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques. | 18 months |