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Evaluation of the Validity of BIS as a Tool for Quantification of Lymphedema Through Comparison With Perometry and Self-Report

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Evaluation of the Validity of BIS as a Tool for Quantification of Lymphedema Through Comparison With Perometry and Self-Report

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

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Correlation of impedance ratios obtained through bioimpedance spectroscopy (BIS)with perometric relative arm volume change (RVC) and self-reported symptom data

Outcome 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 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.

Outcome Time Frame:

5 years

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

December 2011

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms
  • Lymphedema



Massachusetts General HospitalBoston, Massachusetts  02114-2617