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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIS | Subjects evaluated using Bioimpedance Spectroscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioimpedance Spectroscopy | Other | BIS used to measure fluid in arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Relationship Between Lymphedema Diagnostic Criteria Corresponding to BIS, Perometry, and Self-reported Symptoms | 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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Inclusion Criteria:
Exclusion Criteria:
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Subjects with histologically or cytologically confirmed breast cancer who will be returning routinely for follow-up at Massachusetts General Hospital
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34506083 | Background | 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. |
| Label | URL |
|---|---|
| Gillespie 2021 Publication Link | View source |
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270 participants were accrued, however 65 had to be excluded because they later received bilateral breast surgery and 14 withdrew consent. This is why 191 participants started the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bioimpedance Sprectroscopy | Subjects evaluated using Bioimpedance Spectroscopy Bioimpedance Spectroscopy: BIS used to measure fluid in arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants included in analysis who had at least one post-operative follow up measurement
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| ID | Title | Description |
|---|---|---|
| BG000 | Bioimpedance Spectroscopy | Subjects evaluated using Bioimpedance Spectroscopy Bioimpedance Spectroscopy: BIS used to measure fluid in arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 53 of the 191 participants had to be excluded. 27 lost to follow up, 4 died on the study, 3 had disease progression, and baseline measurements were not available for 19 participants. | Posted | Number | correlation coefficient | 5 years | measurements | measurements |
|
7 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bioimpedance Spectroscopy | Subjects evaluated using Bioimpedance Spectroscopy Bioimpedance Spectroscopy: BIS used to measure fluid in arm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Lymphedema Research Program | Massachusetts General Hospital | 6177240127 | cbrunelle@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2019 | Aug 16, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 4, 2019 | Aug 16, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 5 years |
| Baseline Measurements not Available |
|
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects evaluated using Bioimpedance Spectroscopy
Bioimpedance Spectroscopy: BIS used to measure fluid in arm
|
|
|
| Secondary | Compare Relationship Between Lymphedema Diagnostic Criteria Corresponding to BIS, Perometry, and Self-reported Symptoms | 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. | This data was not collected and outcome cannot be reported. | Posted | 5 years |
|
|
| 4 |
| 191 |
| 0 |
| 191 |
| 0 |
| 191 |
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| D017437 |
| Skin and Connective Tissue Diseases |