Clinical trial · Observational
Evaluation of BIS for Quantification of Lymphedema
Evaluation of the Validity of BIS as a Tool for Quantification of Lymphedema Through Comparison With Perometry and Self-Report
NCT01544335CI-TRIAL-00078329completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bioimpedance Spectroscopy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- BIS
- description
- Subjects evaluated using Bioimpedance Spectroscopy
- interventionNames
- Other: Bioimpedance Spectroscopy
Primary outcomes (1)
- measure
- Correlation of Impedance Ratios Obtained Through Bioimpedance Spectroscopy (BIS) With Perometric Relative Arm Volume Change (RVC)
- timeFrame
- 5 years
- description
- 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 in the LEFT-BC questionnaires completed during each examination. Volumetric arm measurements from perometry will be quantified using the RVC formula, which will be compared with impedance ratios calculated using the BIS device software.
Secondary outcomes (1)
- measure
- Compare Relationship Between Lymphedema Diagnostic Criteria Corresponding to BIS, Perometry, and Self-reported Symptoms
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDGillespie TC, Roberts SA, Brunelle CL, Bucci LK, Bernstein MC, Daniell KM, Naoum GN, Miller CL, Taghian AG. Comparison of perometry-based volumetric arm measurements and bioimpedance spectroscopy for early identification of lymphedema in a prospectively-screened cohort of breast cancer patients. Lymphology. 2021;54(1):1-11. PMID 34506083