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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2012

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.

Interventions

  • Device: Garment Sleeve
    • compression sleeve (20 to 30 mm of Hg)

Arms, Groups and Cohorts

  • No Intervention: Observation
    • Observation arm will continue to be followed with serial L-Dex and water volume displacement methods.
  • Other: 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.

Clinical Trial Outcome Measures

Primary Measures

  • To determine whether early intervention in patients with pre-clinical lymphedema can halt the progression of lymphedema.
    • Time Frame: 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 Measures

  • 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)
    • Time Frame: 2 years
    • Evaluate whether bioimpedance analysis is better than the gold standard of volume displacement for measuring lymphedema.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Main Line Health
  • Collaborator
    • Sharpe-Strumia Research Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andrea V Barrio, MD, Principal Investigator, Bryn Mawr Hospital
  • Overall Contact(s)
    • Marita Truax, RN, BSN, 484-337-8712, TruaxM@mlhs.org

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