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Active Clinical Trials

Bioimpedance Spectroscopy versus Tape Measurement

Active NCT:
02167659
Federal North Building on the North Side
Federal North Building on the North Side

Allegheny General Hospital
Allegheny General Hospital

Wexford Health + Wellness Pavilion
Wexford Health + Wellness Pavilion

Category:
Cancer - Breast
Sponsor: 
ImpediMed Limited
Contact: 

For more information, please contact Dawn Kolar by telephone at 412-359-8162 or Dawn.Kolar@ahn.org or Ashley Young by telephone at 412-359-6458 or Ashley.Young@ahn.org

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

Purpose: 

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

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