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



Status:Active, not recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/15/2018
Start Date:June 2014
End Date:December 2020

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A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement in the Prevention of Lymphedema Following Locoregional Treatment for Breast Cancer (PREVENT)

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.

The treatment of lymphedema following breast cancer therapy is typically a burdensome
multi-modality process that entails different degrees of intensity depending on the severity
of fluid accumulation. In breast cancer survivors, it is most commonly initiated after
visible swelling occurs in a limb. Common treatments utilized are multi-modality and include
massage, compression, exercises, and skin care. The current gold standard treatment for
advanced fluid accumulation is complex decongestive physiotherapy (CDP). CDP includes
components of compression, lymphatic drainage, skin care, and exercise and is commonly
delivered in two phases with the first phase being a several week course delivered in the
outpatient clinical setting and the second a home maintenance program. CDP is considered the
gold standard due to prospective data demonstrating its efficacy, a series of 537 patients
found significant arm volume decreases with CDP and subsequent studies have confirmed volume
reductions along with improved quality of life in those patients undergoing CDP. Studies
comparing CDP to other treatment modalities are limited but some have favored CDP. CDP is
limited in that access to long term prospective follow-up treatment may not take place and it
requires significant resources and costs.

Recent studies have suggested that early diagnosis and treatment allow for less burdensome
and aggressive therapy utilization moving forward. Increasing data support the idea that
early intervention improves outcomes for women with lymphedema following breast cancer
treatment. Recent prospective data have shown that with a short course of compression therapy
(sleeve and gauntlet), ranging from 4 to 6 weeks, the rate of progression of fluid
accumulation is limited. Specifically, the Stout Gergich et al. study provided sound
preliminary data to support that four weeks of treatment using a 20-30 mmHg compression
garment and gauntlet can, over 18 months of post intervention follow-up, reduce volume and
prevent the need for CDP.

These findings are encouraging; however, it should be noted that these studies have
significant limitations including small patient numbers, limited follow up, a lack of
randomization, and a lack of subclinical detection of increasing extracellular fluid.
Therefore, while some data exist that suggest that early intervention with clinically
apparent extracellular fluid accumulation is beneficial, there are less data to support the
hypothesis that subclinical detection and subsequent early intervention are beneficial. Based
on data from these studies, it may be possible to prevent chronic lymphedema with early
detection and intervention. Early detection may be best achieved by identifying changes in
extracellular fluid instead of change in whole arm volume. Given the potential to improve
patient outcomes and possibly prevent chronic lymphedema, additional research is warranted in
large randomized trials that address some of the limitations of the previous work.

BIS is a technology designed to identify changes in extracellular fluid. The investigators
propose to determine if subclinical detection of increasing extracellular fluid via BIS and
subsequent early treatment with four weeks of a compression sleeve and gauntlet results in a
reduction in the rates of progression to chronic lymphedema as compared to the same
intervention when initiated from use of the most common arm measurement method (tape
measurement).

The investigators will secondarily explore selective correlatives related to lymphedema and
lymphedema progression. As multiple factors may lead to lymphedema, the influence of
potential risk factors on lymphedema progression will be evaluated. Time to actual
progression will also be examined. Because lymphedema results in problematic symptoms and
diminished quality of life, correlatives using validated instruments will also be examined.

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
We found this trial at
10
sites
4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Sarah McLaughlin, MD
Phone: 904-953-2000
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Jacksonville, FL
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Cape Girardeau, Missouri 63703
Principal Investigator: Andrew Moore, MD
Phone: 573-519-4830
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Cape Girardeau, MO
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Sarah DeSnyder, MD
Phone: 713-794-3096
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Jamie Wagner, MO
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Kansas City, KS
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Phone: 502-629-3387
University of Louisville The University of Louisville is a state supported research university located in...
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Louisville, KY
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Sheila Ridner, PhD
Phone: 615-322-0831
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Nashville, TN
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New York, NY
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Pittsburgh, Pennsylvania 15212
Phone: 412-359-8720
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Pittsburgh, PA
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Richmond, Virginia 23298
Principal Investigator: Douglas Arthur, MD
Phone: 804-828-7232
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Richmond, VA
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Sydney, New South Wales 2113
Principal Investigator: John Boyages, PhD
Phone: +61 2 9812 3508
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Sydney,
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