Evaluation of BIS for Quantification of Lymphedema

NCT01544335 | Completed Results DMC

• 1 other identifier: 11-325
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Correlation of Impedance Ratios Obtained Through Bioimpedance Spectroscopy (BIS) With Perometric Relative Arm Volume Change (RVC)

  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.

  5 years

Secondary Outcomes (1)

• Compare Relationship Between Lymphedema Diagnostic Criteria Corresponding to BIS, Perometry, and Self-reported Symptoms

  5 years

Study Arms (1)

BIS

Subjects evaluated using Bioimpedance Spectroscopy

Other: Bioimpedance Spectroscopy

Interventions

Bioimpedance Spectroscopy OTHER

BIS used to measure fluid in arm

BIS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Gillespie 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 BACKGROUND

Related Links

• Gillespie 2021 Publication Link

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Associate Director, Lymphedema Research Program
• Organization: Massachusetts General Hospital

cbrunelle@mgh.harvard.edu

6177240127

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2012
• First Posted: March 5, 2012
• Study Start: December 1, 2011
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: June 27, 2024
• Results First Posted: November 17, 2021

Record last verified: 2024-06

Locations

US (1)