Bioimpedance Spectroscopy Versus Tape Measure in Prevention of Lymphedema

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.

Eligibility 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

- Bilateral breast cancer or planned bilateral mastectomy

Principal Investigator

Jamie Wagner, MO

Study Contact

Jamie Wagner, DO, jwagner@kumc.edu

Estimated Completion Date

Saturday, June 1, 2019

ClinicalTrials.gov #

NCT02167659
04/29/2015