Evaluation of BIS for Quantification of Lymphedema
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of the Validity of BIS as a Tool for Quantification of Lymphedema Through Comparison With Perometry and Self-Report|
- Correlation of impedance ratios obtained through bioimpedance spectroscopy (BIS)with perometric relative arm volume change (RVC) and self-reported symptom data [ Time Frame: 5 years ] [ Designated as safety issue: No ]Correlation of volumetric measurements obtained using Perometry with impedance ratios obtained through BIS at the baseline examination and during follow-up visits. Impedance ratios will also be correlated with symptoms indicated inthe LEFT-BC questionnaires completed during each examination. Volumetric arm measurements from perometry will be quantified using the RVC formula, which will be compared with imepdance ratios calculated using the BIS device software.
- Compare relationship between lymphedema diagnostic criteria corresponding to BIS, perometry, and self-reported symptoms [ Time Frame: 5 years ] [ Designated as safety issue: No ]Relationship among diagnostic criteria pertaining to BIS, perometry, and self-reported symptoms. A change of >3 Standard Deviations in impedance ratios compared to pre-surgical baseline is considered diagnostic for lymphedema when BIS is utilized. A relative volume change of >5% - >10% compared to baseline is considered lymphedema by perometry. Self-report of symptoms including feelings of swelling, heaviness, and tightness are often considered as criteria for lymphedema.
|Study Start Date:||December 2011|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Subjects evaluated using Bioimpedance Spectroscopy
Other: Bioimpedance Spectroscopy
BIS used to measure fluid in arm
During the study whenever you have an arm volume measurement using the Perometer, we will also measure the fluid in your arms using Bioimpedance Spectroscopy. These measurements are made by passing a harmless electrical signal of very low strength through your body to determine the difference in the amount of fluid in each arm. The test is simple and painless, and takes about 3 minutes. In addition, whenever you have an arm measurement, you will be asked to complete a questionnaire. While completing the questionnaire, you can skip any questions you do not wish to answer. The questionnaires will take about 10 minutes to complete. Arm measurements with the Perometer and Bioimpedance Spectroscopy and completion of the questionnaire will occur every 4-7 months when you are at MGH for regular medical visits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544335
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Alphonse Taghian, MD,PhD 617-726-6050 firstname.lastname@example.org|
|Principal Investigator: Alphonse Taghian, MD,PhD|