Evaluation of BIS for Quantification of Lymphedema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01544335
Recruitment Status : Recruiting
First Posted : March 5, 2012
Last Update Posted : March 21, 2018
Information provided by (Responsible Party):
Alphonse Taghian, MD, PhD, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment
Breast Cancer Other: Bioimpedance Spectroscopy

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 200 participants
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
Study Start Date : December 2011
Estimated Primary Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema
U.S. FDA Resources

Group/Cohort Intervention/treatment
Subjects evaluated using Bioimpedance Spectroscopy
Other: Bioimpedance Spectroscopy
BIS used to measure fluid in arm

Primary Outcome Measures :
  1. 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 ]
    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 Outcome Measures :
  1. Compare relationship between lymphedema diagnostic criteria corresponding to BIS, perometry, and self-reported symptoms [ Time Frame: 5 years ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with histologically or cytologically confirmed breast cancer who will be returning routinely for follow-up at Massachusetts General Hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01544335

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Alphonse Taghian, MD,PhD    617-726-6050   
Principal Investigator: Alphonse Taghian, MD,PhD         
Sponsors and Collaborators
Massachusetts General Hospital

Responsible Party: Alphonse Taghian, MD, PhD, Principal Investigator, Massachusetts General Hospital Identifier: NCT01544335     History of Changes
Other Study ID Numbers: 11-325
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Lymphatic Diseases