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

Breast Cancer Clinical Trial

— L-Dex  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01521000
• Other study ID #: F/N-R10-2932B
• Status: Recruiting
• Phase: N/A
• First received: February 9, 2011
• Last updated: January 25, 2012
• Start date: July 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2012
• Source: Main Line Health
• Contact: Marita Truax, RN, BSN
• Phone: 484-337-8712
• Email: TruaxM[@]mlhs.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema

Intervention

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

Locations

Country	Name	City	State
United States	Comprehensive Breast Center at Bryn Mawr Hospital	Bryn Mawr	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Main Line Health	Sharpe-Strumia Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No