Reducing the Incidence and Severity of Arm Lymphedema With Axillary Reverse Mapping and Implementation of a Lymphedema Screening and Intervention Program
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Whether or not a patient has developed Grade 1+ LE
During the first year post-operatively
No
Dennis Holmes
Principal Investigator
USC/Norris Comprehensive Cancer Center
United States: Food and Drug Administration
1B-09-12
NCT01276054
December 2010
October 2011
Name | Location |
---|---|
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |