NCT00932035

Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer

Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation Surgery

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This pilot phase I and randomized phase II trial studies the best way to perform axillary lymph node preservation surgery and to see how well it works in preventing lymphedema in patients with breast cancer. Lymph node mapping may help in planning surgery to remove breast cancer and affected lymph nodes. It is not yet known whether reverse mapping guided axillary lymph node dissection is more effective than standard axillary lymph node dissection in preventing lymphedema.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	axillary lymph node dissection	Undergo reverse mapping-guided axillary lymph node dissection
DRUG	isosulfan blue based lymphatic mapping
PROCEDURE	axillary lymph node dissection	Undergo standard axillary lymph node dissection
PROCEDURE	quality-of-life assessment	Ancillary studies
OTHER	Questionnaire administration	Ancillary studies

Timeline

• Start date: 2009-06-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2009-07-02
• Last updated: 2017-06-07
• Results posted: 2017-06-07

Locations

3 sites across 1 country: United States