NCT01276054

Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.

Reducing the Incidence and Severity of Arm Lymphedema With Axillary Reverse Mapping and Implementation of a Lymphedema Screening and Intervention Program

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the ability of axillary reverse mapping (ARM) to reduce the incidence of lymphedema (LE) following axillary nodal staging. SECONDARY OBJECTIVES: I. To document the use of a standardized LE screening and LE level-specific management protocol on the outcome of LE among patients who develop LE. II. To document the relationship between limb volume measurements assessed by infrared laser perometry and bioelectrical impedance spectroscopy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo and axillary reverse mapping. ARM II: Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. After completion of study treatment, patients are followed up at 1-2 weeks, 3 months, and then every 6 months for 4 years.

Conditions

• Lymphedema
• Recurrent Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer

Interventions

Type	Name	Description
RADIATION	technetium Tc 99m sulfur colloid	Given intradermally and periareolarly
DRUG	methylene blue	Given subcutaneously
DRUG	indocyanine green solution	Given subcutaneously
PROCEDURE	sentinel lymph node biopsy	Undergo sentinel lymph node biopsy
PROCEDURE	axillary lymph node biopsy	Undergo axillary lymph node biopsy
PROCEDURE	bioimpedance spectroscopy	Correlative studies
PROCEDURE	quality-of-life assessment	Ancillary studies
OTHER	lymphedema management	Undergo axillary reverse mapping

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-01-13
• Last updated: 2014-08-01
• Results posted: 2014-08-01

Locations

1 site across 1 country: United States