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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Main Line Health.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sharpe-Strumia Research Foundation
Information provided by (Responsible Party):
Main Line Health
ClinicalTrials.gov Identifier:
NCT01521000
First received: February 9, 2011
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention
Breast Cancer
Device: Garment Sleeve

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient

Resource links provided by NLM:


Further study details as provided by Main Line Health:

Primary Outcome Measures:
  • To determine whether early intervention in patients with pre-clinical lymphedema can halt the progression of lymphedema. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    Evaluate whether bioimpedance analysis is better than the gold standard of volume displacement for measuring lymphedema.


Estimated Enrollment: 200
Study Start Date: July 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Garment Sleeve
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)
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521000

Contacts
Contact: Marita Truax, RN, BSN 484-337-8712 TruaxM@mlhs.org
Contact: Eileen A Morgans, RN,BSN,CBCN 484-337-8744 morgansE@mhls.org

Locations
United States, Pennsylvania
Comprehensive Breast Center at Bryn Mawr Hospital Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Principal Investigator: Andrea V Barrio, MD         
Sponsors and Collaborators
Main Line Health
Sharpe-Strumia Research Foundation
Investigators
Principal Investigator: Andrea V Barrio, MD Bryn Mawr Hospital
  More Information

No publications provided

Responsible Party: Main Line Health
ClinicalTrials.gov Identifier: NCT01521000     History of Changes
Other Study ID Numbers: F/N-R10-2932B
Study First Received: February 9, 2011
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Main Line Health:
Breast Cancer
Lymphedema
Sentinel Node Biopsy
Axillary Dissection

Additional relevant MeSH terms:
Lymphedema
Breast Neoplasms
Lymphatic Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014