Active Clinical Trials
Bioimpedance Spectroscopy versus Tape Measurement
A Randomized Trial Evaluating Bioimpedance Spectroscopy versus Tape Measurement in the Prevention of Lymphedema following Locoregional Treatment for Breast Cancer
Based upon the current state of science, the investigators are proposing to conduct a randomized clinical trial in which participants are randomized post-surgery to either BIS or circumferential (tape) measurements for follow-up arm measurements. When patients in the BIS group have an L-Dex change that is ≥10 units higher than the pre-surgical baseline measure, and when patients in the tape measurement group have a volume change in the at-risk arm that is between ≥ 5% and < 10% above pre-surgical baselines (without similar change in non-at-risk arm), both will receive four weeks of 23-32 mm compression sleeve and gauntlet therapy.
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
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