Clinical trial NCT02167659: Bioimpedance Spectroscopy Versus Tape Measure in Prevention of Lymphedema (PREVENT)
Official title: A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement in the Prevention of Lymphedema Following Locoregional Treatment for Breast Cancer (PREVENT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Keywords: Lymphedema
Breast cancer
Bioimpedance Spectroscopy
L-Dex
Lead sponsor: ImpediMed Limited
Sponsor class: INDUSTRY
Collaborators: name: Vanderbilt University
name: Macquarie University, Australia
First posted: 2014-06-19
Enrollment: 1201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

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

Primary outcomes:
measure: Rate of progression of lymphedema
timeFrame: 3 years
Secondary outcomes:
measure: Number of participants with risk factors associated with lymphedema.
timeFrame: 3 years
measure: Time elapsed between identification of increasing fluid and referral out of study for continued swelling.
timeFrame: 3 years
measure: Number of participants with improved skin condition, symptoms and quality of life.
timeFrame: 3 years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Cape Girardeau
country: United States
facility: Southeast Health
state: Missouri
city: New York
country: United States
facility: New York Presbyterian - University Hospital of Columbia and Cornell
state: New York
city: Pittsburgh
country: United States
facility: Allegheny Health Research Institute
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Richmond
country: United States
facility: Massey Cancer Center
state: Virginia
city: Sydney
country: Australia
facility: Macquarie University
state: New South Wales
Study officials:
affiliation: Vanderbilt University
name: Sheila H Ridner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dietrich MS, Gaitatzis K, Koelmeyer L, Boyages J, Abramson VG, McLaughlin SA, Ngui N, Elder E, French J, Hsu J, Hughes TM, Stolldorf DP, Shah C, Ridner SH. Prospective Surveillance with Compression for Subclinical Lymphedema: Symptoms, Skin, and Quality-of-Life Outcomes. Lymphat Res Biol. 2023 Jun;21(3):304-313. doi: 10.1089/lrb.2022.0020. Epub 2022 Sep 20.
citation: Ridner SH, Dietrich MS, Boyages J, Koelmeyer L, Elder E, Hughes TM, French J, Ngui N, Hsu J, Abramson VG, Moore A, Shah C. A Comparison of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Breast Cancer Lymphedema Prevention. Lymphat Res Biol. 2022 Dec;20(6):618-628. doi: 10.1089/lrb.2021.0084. Epub 2022 Jan 28.