Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- 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
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03941756
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Mark Schaverien M.D. Anderson Cancer Center