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

NCT00932035 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-06-07

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Steven Chen, MD · City of Hope Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00932035 on ClinicalTrials.gov