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Clinical Trial VICCBRE1438

Title

A Randomized Trial Evaluating Bioimpedance Spectroscopy versus Tape Measurement in the Prevention of Lymphedema following Locoregional Treatment for Breast Cancer

Principal Investigator(s)

Sheila Ridner

Details

  • 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

Description

None Provided.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• 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.
Exclusion Criteria:
• 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