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

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 Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Garment Sleeve

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Recruiting
      • Comprehensive Breast Center at Bryn Mawr Hospital
      • Principal Investigator: Andrea V Barrio, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Observation; Observation arm will continue to be followed with serial L-Dex and water volume displacement methods.	Device: Garment Sleeve; compression sleeve (20 to 30 mm of Hg)
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.	Device: Garment Sleeve; compression sleeve (20 to 30 mm of Hg)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Main Line Health
• Collaborators: Sharpe-Strumia Research Foundation
• Investigators: Principal Investigator: Andrea V Barrio, MD, Bryn Mawr Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: February 9, 2011
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (Estimate): January 30, 2012

Study Record Updates

• Last Update Posted (Estimate): January 30, 2012
• Last Update Submitted That Met QC Criteria: January 25, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Lymphedema; Breast Cancer; Sentinel Node Biopsy; Axillary Dissection
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Lymphedema
• Other Study ID Numbers: F/N-R10-2932B