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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02167659




Registration number
NCT02167659
Ethics application status
Date submitted
12/06/2014
Date registered
19/06/2014
Date last updated
11/01/2021

Titles & IDs
Public title
Bioimpedance Spectroscopy Versus Tape Measure in Prevention of Lymphedema (PREVENT)
Scientific title
A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement in the Prevention of Lymphedema Following Locoregional Treatment for Breast Cancer (PREVENT)
Secondary ID [1] 0 0
VICCBRE1438
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphedema 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - 23-32 mmHg compression sleeve with gauntlet

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.


Treatment: Devices: 23-32 mmHg compression sleeve with gauntlet
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of progression of lymphedema
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Number of participants with risk factors associated with lymphedema.
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Time elapsed between identification of increasing fluid and referral out of study for continued swelling.
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Number of participants with improved skin condition, symptoms and quality of life.
Timepoint [3] 0 0
3 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2020
Sample size
Target
Accrual to date
Final
1201
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Macquarie University - Sydney
Recruitment postcode(s) [1] 0 0
2109 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ImpediMed Limited
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Vanderbilt University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Macquarie University, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02167659
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sheila H Ridner, PhD
Address 0 0
Vanderbilt University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02167659