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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01521000

Acronym

L-Dex

Enrollment

200

Registered

2012-01-30

Start date

2010-07-31

Completion date

2012-12-31

Last updated

2012-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Lymphedema, Sentinel Node Biopsy, Axillary Dissection

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

Interventions

DEVICEGarment Sleeve

compression sleeve (20 to 30 mm of Hg)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
To determine whether early intervention in patients with pre-clinical lymphedema can halt the progression of lymphedema.	2 years	Evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease.

Secondary

Measure	Time frame	Description
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)	2 years	Evaluate whether bioimpedance analysis is better than the gold standard of volume displacement for measuring lymphedema.

Countries

United States

Contacts

Primary ContactMarita Truax, RN, BSN

TruaxM@mlhs.org484-337-8712

Backup ContactEileen A Morgans, RN,BSN,CBCN

morgansE@mhls.org484-337-8744

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026