- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01521000
The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient (L-Dex)
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
Study Overview
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marita Truax, RN, BSN
- Phone Number: 484-337-8712
- Email: TruaxM@mlhs.org
Study Contact Backup
- Name: Eileen A Morgans, RN,BSN,CBCN
- Phone Number: 484-337-8744
- Email: morgansE@mhls.org
Study Locations
-
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Pennsylvania
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Bryn Mawr, Pennsylvania, United States, 19010
- Recruiting
- Comprehensive Breast Center at Bryn Mawr Hospital
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Principal Investigator:
- Andrea V Barrio, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Observation
Observation arm will continue to be followed with serial L-Dex and water volume displacement methods.
|
compression sleeve (20 to 30 mm of Hg)
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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.
|
compression sleeve (20 to 30 mm of Hg)
|
What is the study measuring?
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.
Time Frame: 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.
|
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)
Time Frame: 2 years
|
Evaluate whether bioimpedance analysis is better than the gold standard of volume displacement for measuring lymphedema.
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrea V Barrio, MD, Bryn Mawr Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F/N-R10-2932B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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