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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.

NCT01276054 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2014-08-01

Study results available
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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

Conditions

  • Lymphedema
  • Recurrent Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer

Interventions

RADIATION

technetium Tc 99m sulfur colloid

Given intradermally and periareolarly

DRUG

methylene blue

Given subcutaneously

DRUG

indocyanine green solution

Given subcutaneously

PROCEDURE

sentinel lymph node biopsy

Undergo sentinel lymph node biopsy

PROCEDURE

axillary lymph node biopsy

Undergo axillary lymph node biopsy

PROCEDURE

bioimpedance spectroscopy

Correlative studies

PROCEDURE

quality-of-life assessment

Ancillary studies

OTHER

lymphedema management

Undergo axillary reverse mapping

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Southern California

    lead OTHER

Principal Investigators

  • Dennis Holmes · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01276054 on ClinicalTrials.gov