A Study Using Bioimpedance Spectroscopy versus Tape Measurement in Catching and Intervening in the Early Onset of Lymphedema

Overview

About this study

The purpose of this study is to compare the use of Bioimpedance Spectroscopy versus tape measurements for follow-up arm measurements after regional treatment for breast cancer. Catching the smallest increases in fluid buildup and intervening early may result in a decrease in the rate of progressions to chronic lymphedema. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 Bioimpedance Spectroscopy 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Sarah McLaughlin, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20491220

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