Clinical trial NCT01521000: The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient
Official title: The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Lymphedema
Sentinel Node Biopsy
Axillary Dissection
Lead sponsor: Main Line Health
Sponsor class: OTHER
Collaborators: name: Sharpe-Strumia Research Foundation
First posted: 2012-01-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: To determine whether early intervention in patients with pre-clinical lymphedema can halt the progression of lymphedema.
timeFrame: 2 years
Secondary outcomes:
measure: 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)
timeFrame: 2 years
Other outcomes:
Locations:
city: Bryn Mawr
country: United States
facility: Comprehensive Breast Center at Bryn Mawr Hospital
state: Pennsylvania
Study officials:
affiliation: Bryn Mawr Hospital
name: Andrea V Barrio, MD
role: PRINCIPAL_INVESTIGATOR
References: