Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation Surgery
PRIMARY OBJECTIVES: I. To produce a map of the lymphatic drainage of the upper extremity as
it relates to breast drainage, to determine the proportion of women undergoing axillary
lymphadenectomy at risk for lymphedema. II. To determine if blue lymphatics contain lymph
node metastases. III. To evaluate the incidence of lymphedema and associated other surgical
related quality of life in those undergoing this procedure as compared to the current
standard of care.
OUTLINE: This is a phase I study followed by a randomized phase II study.
PILOT PORTION: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo
reverse mapping-guided axillary lymph node dissection.
RANDOMIZED PORTION: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients
receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided
axillary lymph node dissection. ARM II: Patients undergo standard axillary lymph node
dissection and then receive isosulfan blue dye SC.
After completion of study treatment, patients are followed up periodically.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Percentage of patients with arm lymphatics above, at, or below the axillary vein (Pilot)
A Fisher's exact test with a one-sided alpha of 0.05 will be used.
Up to 4 years
Steven Chen, MD
City of Hope Medical Center
United States: Institutional Review Board
|City of Hope Medical Center||Duarte, California 91010|
|University of North Carolina||Chapel Hill, North Carolina 27599|
|University of California, Davis Medical Center||Sacramento, California|