Bioimpedance Spectroscopy Versus Tape Measure in Prevention of Lymphedema (PREVENT)

Completed · Not applicable

Conditions studied: Lymphedema

In brief

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 ≥6.5 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.

Key facts

Study ID

NCT02167659

Run by

ImpediMed Limited

People needed

1201

Starts

2014-06-01

Expected to finish

2020-12-31

Last updated by the study team

2021-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Jacksonville, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Louisville — Louisville, Kentucky, United States
• Southeast Health — Cape Girardeau, Missouri, United States
• New York Presbyterian - University Hospital of Columbia and Cornell — New York, New York, United States
• Allegheny Health Research Institute — Pittsburgh, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Massey Cancer Center — Richmond, Virginia, United States
• Macquarie University — Sydney, New South Wales, Australia

Full record on ClinicalTrials.gov

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