Status:
ACTIVE_NOT_RECRUITING
Subclinical Lymphedema Treatment Study
Lead Sponsor:
Mercy Research
Collaborating Sponsors:
ImpediMed Limited
Conditions:
Breast Cancer-related Subclinical Lymphedema
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Primary Objective * To compare the effectiveness of 2 treatment protocols for patients with breast cancer-related subclinical lymphedema identified through bioimpedance spectroscopy, L-dex scores Se...
Detailed Description
Lymphedema is an accumulation of fluid in the interstitial tissues resulting from an impairment of the normal lymphatic drainage of the affected region. Lymphedema is often a side effect of breast can...
Eligibility Criteria
Inclusion
- New diagnosis of breast cancer, Female, 18 years of age or older, Upcoming unilateral axillary lymph node procedure (biopsy or dissection), Able to provide informed consent
Exclusion
- Pre-existing diagnosis of lymphedema, as diagnosed by physician, History of axillary lymph node procedure, including biopsy, dissection, or radiation to, Pregnancy, Pacemaker or other implanted electrical device, Stage 4-5 kidney disease, Severe liver disease, Active infection, Acute Deep Vein Thrombosis, Unmanaged congestive heart failure or a cardiac event in the past 6 months, Prisoners
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT03292198
Start Date
April 1 2018
End Date
December 1 2025
Last Update
October 22 2025
Active Locations (1)
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1
Mercy David C. Pratt Cancer Center
St Louis, Missouri, United States, 63141