A Study Using Bioimpedance Spectroscopy versus Tape Measurement in Catching and Intervening in the Early Onset of Lymphedema
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 14-004264
NCT ID: NCT02167659
Sponsor Protocol Number: VICCBRE1438
About this study
The purpose of this study is to compare the use of Bioimpedance Spectroscopy versus tape measurements for follow-up arm measurements after regional treatment for breast cancer. Catching the smallest increases in fluid buildup and intervening early may result in a decrease in the rate of progressions to chronic lymphedema.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 Bioimpedance Spectroscopy 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Sarah McLaughlin, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available