The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient
NCT ID: NCT01521000
Last Updated: 2012-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2010-07-31
2012-12-31
Brief Summary
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Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema.
Tertiary Objective: To determine whether bioimpedance analysis is better than the gold standard of volume displacement to measure lymphedema.
The successful completion of this study will address whether bioimpedance analysis is a reliable, accurate method to measure pre-clinical and clinical lymphedema. In addition, we intend to evaluate whether bioimpedance analysis is better than the gold standard of volume displacement for measuring lymphedema. And most importantly, we will evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease. Bryn Mawr Hospital would propose to publish the research and findings of this study, which may have future bearing on the post-operative therapeutic management of subjects with pre-clinical lymphedema following axillary surgery.
Study Design:Randomized, Pilot Study
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Detailed Description
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Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema.
Tertiary Objective: To determine whether bioimpedance analysis is better than the gold standard of volume displacement to measure lymphedema.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Observation
Observation arm will continue to be followed with serial L-Dex and water volume displacement methods.
Garment Sleeve
compression sleeve (20 to 30 mm of Hg)
Intervention-garment sleeve
If the L-Dex is outside the normal range, or has increased 10 units from baseline, the patient will then be randomized to wear a compression sleeve (20 to 30 mm of Hg) daily for 4 weeks or observation (no sleeve). After 4 weeks, L-Dex measurements and water volume displacement will be reassessed in the treatment group.
Garment Sleeve
compression sleeve (20 to 30 mm of Hg)
Interventions
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Garment Sleeve
compression sleeve (20 to 30 mm of Hg)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Sharpe-Strumia Research Foundation
OTHER
Main Line Health
OTHER
Responsible Party
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Principal Investigators
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Andrea V Barrio, MD
Role: PRINCIPAL_INVESTIGATOR
Bryn Mawr Hospital
Locations
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Comprehensive Breast Center at Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Countries
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Central Contacts
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Other Identifiers
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F/N-R10-2932B
Identifier Type: -
Identifier Source: org_study_id
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