Clinical Trial VICCBRE1438
A Randomized Trial Evaluating Bioimpedance Spectroscopy versus Tape Measurement in the Prevention of Lymphedema following Locoregional Treatment for Breast Cancer
- Protocol No. VICCBRE1438
- Open Date: 06/19/2014
- Staging: N/A
- Age Group: Adults
- Scope: International
- Objective: To determine if subclinical detection of extracellular fluid accumulation via bioimpedance spectroscopy and subsequent early intervention reduce the rate of progression to CDP relative to rates seen using standard tape measurements.
- Disease Sites: Breast; Supportive Care
- Therapies: Supportive Care
- Drugs: None Specified
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT02167659
- Secondary Protocol No: Not Specified
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
• Histologically confirmed invasive breast cancer or Ductal Carcinoma In Situ (DCIS)
• Planned surgical procedure
• Ability to understand and the willingness to sign a written informed consent document.
• Prior history of breast cancer, breast/chest wall/axillary radiation therapy
• Definitive breast surgical procedure prior to enrollment.
• Active implanted medical device (e.g., cardiac pacemakers, defibrillators) or patients connected to electronic life support devices or metallic devices that would interfere with BIS measurements.
• Conditions that could cause swelling (e.g., pregnancy, congestive heart failure, chronic/acute renal disease, cor pulmonale, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, and thrombophlebitis, or deep vein thrombosis in arms
• Previous treatment for lymphedema of either arm.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or cardiac arrhythmia.
• Psychiatric illness (e.g., diagnosed schizophrenia or documented dementia) that would limit compliance with study requirements.
• Known allergy to electrode adhesives or woven knit compression fabrics
• Bilateral breast cancer or planned bilateral mastectomy