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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Garment Sleeve


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observation<br>Observation arm will continue to be followed with serial L-Dex and water volume displacement methods. | Device: Garment Sleeve<br>* compression sleeve (20 to 30 mm of Hg)<br>|
| Other: Intervention-garment sleeve<br>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. | Device: Garment Sleeve<br>* compression sleeve (20 to 30 mm of Hg)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Lymphedema, Sentinel Node Biopsy, Axillary Dissection