NCT02167659

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 19, 2014

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

6.6 years

First QC Date

June 12, 2014

Last Update Submit

January 7, 2021

Conditions

Lymphedema

Keywords

LymphedemaBreast cancerBioimpedance SpectroscopyL-Dex

Outcome Measures

Primary Outcomes (1)

  • Rate of progression of lymphedema

    To determine if subclinical detection of extracellular fluid accumulation via bioimpedance spectroscopy and subsequent early intervention reduce the rate of progression to CDP relative to rates seen using standard tape measurements.

    3 years

Secondary Outcomes (3)

  • Number of participants with risk factors associated with lymphedema.

    3 years

  • Time elapsed between identification of increasing fluid and referral out of study for continued swelling.

    3 years

  • Number of participants with improved skin condition, symptoms and quality of life.

    3 years

Study Arms (2)

BIS Assessment

EXPERIMENTAL

Patients will undergo measurements by trained staff. Measurements will be performed pre-op and at 3, 6, 12, 15\*, 18, 21\*, 24, and 36 months post-op. Measures include L-Dex, skin assessment and self-report forms. Patients with \< 6.5 L-Dex units change will continue follow-up for 36 months. Patients with an L-Dex value change ≥ 6.5 will undergo circumference measurement and begin treatment for 4 weeks with a 23-32 mmHg compression sleeve with gauntlet. At the end of 4 weeks patients will have their arms measured. Those demonstrating improvement will continue with follow up. Those not demonstrating improvement will be removed from the study and their medical oncologist or surgeon will be notified. \*At discretion of the site PI or attending physicians.

Device: 23-32 mmHg compression sleeve with gauntlet

Tape Measure

ACTIVE COMPARATOR

Patients will undergo measurements by trained staff. Measurements will be performed pre-op and at 3, 6, 12, 15\*, 18, 21\*, 24, and 36 months post-op. Measures include arm volume (tape measure), skin assessment and self-report forms. Patients with no volume increase will continue follow-up for 36 months. Patients with a volume change of between ≥ 5% and \< 10% in the at-risk limb will undergo L-Dex testing and begin treatment for 4 weeks with a 23-32 mmHg compression sleeve with gauntlet. At the end of 4 weeks patients will have their arms measured. Those demonstrating improvement will continue with follow up. Those not demonstrating improvement will be removed from the study and their medical oncologist or surgeon will be notified. \*At discretion of the site PI or attending physicians.

Device: 23-32 mmHg compression sleeve with gauntlet

Interventions

23-32 mmHg compression sleeve with gauntletDEVICE

A compression intervention consisting of a sleeve and gauntlet with 23-32mm of tension worn for four weeks that is initiated based on a BIS L-Dex change that is ≥6.5 units higher than pre-surgical baseline measure, or a tape measurement guided volume change in the affected arm that is between ≥5% and \<10% above pre-surgical baseline.

Also known as: mediven harmony
BIS AssessmentTape Measure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Louisville

Louisville, Kentucky, 40202-1798, United States

Location

Southeast Health

Cape Girardeau, Missouri, 63703, United States

Location

New York Presbyterian - University Hospital of Columbia and Cornell

New York, New York, 10032, United States

Location

Allegheny Health Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

Vanderbilt University

Nashville, Tennessee, 37240, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

Macquarie University

Sydney, New South Wales, 2109, Australia

Location

Related Publications (3)

  • Boyages J, Vicini FA, Manavi BA, Gaw RL, Koelmeyer LA, Ridner SH, Shah C. Axillary Treatment and Chronic Breast Cancer-Related Lymphedema: Implications for Prospective Surveillance and Intervention From a Randomized Controlled Trial. JCO Oncol Pract. 2023 Dec;19(12):1116-1124. doi: 10.1200/OP.23.00060. Epub 2023 Oct 10.

    PMID: 37816208DERIVED

  • 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.

    PMID: 36126315DERIVED

  • 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.

    PMID: 35099283DERIVED

MeSH Terms

Conditions

LymphedemaBreast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sheila H Ridner, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 19, 2014

Study Start

June 1, 2014

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 11, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(9)AU(1)