At a glance
ClinicalIndex Comparison RecordN/ACompleted· 270 enrolled
Drug / intervention
Bioimpedance Spectroscopyother
Likely dose
Not stated in record
Key inclusion· 4
- ✓Histologically or cytologically confirmed invasive or in-situ breast carcinoma
- ✓Must have undergone sentinel node mapping or axillary dissection
- ✓Life expectancy greater than 1 year
- ✓Willing to comply with follow-up Perometer and BIS measurements and LEFT-BC questionnaire completion
Key exclusion· 9
- ✕Known metastatic disease or other locally advanced disease in thoracic or cervical regions
- ✕Will not return routinely for follow-up at MGH or DFHCC
- ✕Known brain metastases
- ✕History of primary lymphedema
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the Validity of BIS as a Tool for Quantification of Lymphedema Through Comparison With Perometry and Self-Report
In Brief
An observational study evaluating Bioimpedance Spectroscopy for Breast Cancer. Completed, enrolled 270 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether measuring the fluid in your arms using Bioimpedance Spectroscopy is as effective at detecting and monitoring lymphedema as measurements with the Perometer. The investigators will also evaluate any symptoms you may experience in your arms during and after treatment for breast cancer with a questionnaire.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2011
First PostedMar 2012
Primary CompletionSep 2020
TodayJul 2026
First PostedMar 5, 2012
Enrollment StartDec 1, 2011
Primary CompletionSep 1, 2020
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 14.3 years ago
Interventions
Bioimpedance Spectroscopyother
BIS used to measure fluid in arm