Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Patients With Resectable Stage 0-II Breast Cancer
| Status: | Archived |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | December 2010 |
Reducing the Incidence and Severity of Arm Lymphedema With Axillary Reverse Mapping and Implementation of a Lymphedema Screening and Intervention Program
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
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.
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