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

Not Applicable

• Conditions: Breast Cancer

• Registration Number: NCT01521000
• Lead Sponsor: Main Line Health

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 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

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 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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-02-09
• Status Verified: 2012-01
• Study First Submitted QC: 2012-01-25
• Last Update Submitted: 2012-01-25
• Study First Posted: 2012-01-30
• Last Update Posted: 2012-01-30
• Primary Completion: 2012-07
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine whether early intervention in patients with pre-clinical lymphedema can halt the progression of lymphedema.	2 years	Evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease.

Secondary Outcome Measures

Name	Time	Method
200 women will have bioimpedance and volume displacement measurements to evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema as compared to standard (volume displacement)	2 years	Evaluate whether bioimpedance analysis is better than the gold standard of volume displacement for measuring lymphedema.

Trial Locations

Locations (1)

Comprehensive Breast Center at Bryn Mawr Hospital; 🇺🇸 Bryn Mawr, Pennsylvania, United States