Recruiting

Bioimpedance

Sponsor:

Main Line Health

Code:

NCT01521000

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Garment Sleeve

Study Details

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

Conditions

Breast Cancer

Study ID

NCT01521000

Start date

Jul, 2010

Status verified date

Jan, 2012

Completion date

Dec, 2012

Anticipated

Primary completion date

Jul, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Observation

Observation arm will continue to be followed with serial L-Dex and water volume displacement methods.

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.

Interventions

Garment Sleeve

compression sleeve (20 to 30 mm of Hg)

Primary outcome measure

  • To determine whether early intervention in patients with pre-clinical lymphedema can halt the progression of lymphedema. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Marita Truax, RN, BSN

484-337-8712TruaxM@mlhs.org

Eileen A Morgans, RN,BSN,CBCN

484-337-8744morgansE@mhls.org

Locations

Comprehensive Breast Center at Bryn Mawr Hospital

Recruiting

Bryn Mawr, Pennsylvania, United States, 19010

Principal Investigator:

Andrea V Barrio, MD

More Information

Sponsor

Main Line Health

Last update posted

Jan 30, 2012

Last verified

Jan, 2012

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Main Line Health on 2012-01-30.