Status:
UNKNOWN
The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient
Lead Sponsor:
Main Line Health
Collaborating Sponsors:
Sharpe-Strumia Research Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Primary Objective: To determine whether early intervention (with garment sleeve and gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema. Secondary Objectives:To ...
Detailed Description
Primary Objective: To determine whether early intervention (with garment sleeve and gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema. Secondary Objectives:To ...
Eligibility Criteria
Inclusion
- are female
- have operable, early stage breast cancer stage 0 - IIIA
- undergo axillary evaluation with either sentinel lymph node biopsy or axillary lymph node dissection
- are aged \> 18 years of age at the date of enrollment
- are willing to sign an informed consent form
Exclusion
- are male
- have had a bilateral axillary surgery
- do not undergo axillary evaluation
- are a minor
- cannot consider the issues involved in making an informed and autonomous decision.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01521000
Start Date
July 1 2010
End Date
December 1 2012
Last Update
January 30 2012
Active Locations (1)
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1
Comprehensive Breast Center at Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010