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.

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)
• Treatments: Methylene Blue; Pharmaceutical Solutions; Technetium Tc 99m Sulfur Colloid

Criteria

Inclusion Criteria:

• Stage 0, I, and II Breast Cancer

• Not pregnant or breastfeeding

• Breast cancer or prophylactic mastectomy requiring axillary nodal staging

• Ability to read and/or comprehend consent form and questionnaires

• Ability to follow-up per protocol

• Unilateral axillary staging

Exclusion Criteria:

• Stage 3

• Previous axillary lymph node dissection

• Neoadjuvant chemotherapy or hormonal therapy exceeding greater than 30 days duration

• Allergy to blue dyes or iodine; NOTE: a non-blue dye or non-iodine-containing dye may be used in these patients

• Patients with implanted medical devices such as a pacemaker may undergo perometry, but not BIS (Bioelectrical Impedance Spectroscopy)

• Previous diagnosis of LE (lymphedema) of either extremity

• Bilateral axillary staging