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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine whether early intervention in patients with pre-clinical lymphedema can halt the progression of lymphedema.

Outcome Description:

Evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Andrea V Barrio, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bryn Mawr Hospital

Authority:

United States: Institutional Review Board

Study ID:

F/N-R10-2932B

NCT ID:

NCT01521000

Start Date:

July 2010

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Lymphedema
  • Sentinel Node Biopsy
  • Axillary Dissection
  • Breast Neoplasms
  • Lymphedema

Name

Location

Comprehensive Breast Center at Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010