The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient

Status unconfirmed · Not applicable

Conditions studied: Breast Cancer

In brief

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 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

Key facts

Study ID

NCT01521000

Run by

Main Line Health

People needed

200

Starts

2010-07-01

Expected to finish

2012-12-01

Last updated by the study team

2012-01-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Comprehensive Breast Center at Bryn Mawr Hospital — Bryn Mawr, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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