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

Status: Completed
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
Mayo Clinic
Jacksonville
Kansas
University of Kansas Medical Center
Kansas City
Kentucky
University of Louisville
Louisville
Missouri
Southeast Health
Cape Girardeau
New York
New York Presbyterian - University Hospital of Columbia and Cornell
New York
Pennsylvania
Allegheny Health Research Institute
Pittsburgh
Tennessee
Vanderbilt University
Nashville
Texas
The University of Texas MD Anderson Cancer Center
Houston
Virginia
Massey Cancer Center
Richmond
Other Locations
Australia
Macquarie University
Sydney
Time Frame
Start Date: 2014-06
Completion Date: 2020-12-31
Participants
Target number of participants: 1201
Treatments
Experimental: BIS Assessment
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.
Active_comparator: Tape Measure
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.
Related Therapeutic Areas
Sponsors
Collaborators: Vanderbilt University, Macquarie University, Australia
Leads: ImpediMed Limited

This content was sourced from clinicaltrials.gov