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

Main Line Health

Status: Unknown

Conditions: Breast Cancer

Treatments: Device: Garment Sleeve

Study type: Interventional

Funder types: Other

Identifiers

NCT01521000

F/N-R10-2932B

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Observation

No Intervention group

Description:

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

Treatment:

Device: Garment Sleeve

Intervention-garment sleeve

Other group

Description:

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.

Treatment:

Device: Garment Sleeve