N/A
N=191
Evaluation of BIS for Quantification of Lymphedema
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01544335 ↗Enrolled (actual)
191
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Correlation of Impedance Ratios Obtained Through Bioimpedance Spectroscopy (BIS) With Perometric Relative Arm Volume Change (RVC) — 0.195 correlation coefficient — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Bioimpedance Spectroscopy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation of Impedance Ratios Obtained Through Bioimpedance Spectroscopy (BIS) With Perometric Relative Arm Volume Change (RVC) |
0.195 | <0.001 sig |
| SECONDARY Compare Relationship Between Lymphedema Diagnostic Criteria Corresponding to BIS, Perometry, and Self-reported Symptoms |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed invasive or in-situ carcinoma of the breast
- Participants must have undergone sentinel node mapping or axillary dissection
- Life expectancy of greater than 1 year.
- Willingness to comply with required follow up Perometer and BIS measurements and completion of LEFT-BC questionnaire
Exclusion Criteria
- Patients who have known metastatic disease or other locally advanced disease in the thoracic or cervical regions
- Any patient who will not be returning routinely for follow-up at MGH or DFHCC
- Participants with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- History of primary lymphedema
- History of prior surgery or radiation to the head, neck, upper limb, or trunk
- Participants who have evidence that axillary lymph node malignancy is causing lymphedema due to recurrence as per physician discretion
- Any patient who has bilateral lymph node mapping or dissection
- Any patient with a current case of cellulitis
- Patients with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
Data sourced from ClinicalTrials.gov (NCT01544335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.