Breast CancerNCT01544335
Evaluation of BIS for Quantification of Lymphedema
An observational study of Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bioimpedance Spectroscopy
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Sep 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with histologically or cytologically confirmed breast cancer who will be returning routinely for follow-up at Massachusetts General Hospital
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
Official title: Evaluation of the Validity of BIS as a Tool for Quantification of Lymphedema Through Comparison With Perometry and Self-Report
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Bioimpedance Spectroscopy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioimpedance SpectroscopyOther
BIS used to measure fluid in arm
| Study group | Role | What they receive |
|---|---|---|
| BIS | Subjects evaluated using Bioimpedance Spectroscopy Receives: Other: Bioimpedance Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startDec 2011
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alphonse Taghian, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544335
- Sponsor's protocol ID
- 11-325
- Status last verified
- Jun 2024
- First submitted
- 12 Feb 2012
- Last updated
- 27 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 34506083
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Validity of BIS as a Tool for Quantification of Lymphedema Through Comparison With Perometry and Self-Report
- ClinicalTrials.gov ID
- NCT01544335
- Acronym / sponsor ID
- 11-325
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Posted 17 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIS | – | Other: Bioimpedance SpectroscopySubjects evaluated using Bioimpedance Spectroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with histologically or cytologically confirmed breast cancer who will be returning routinely for follow-up at Massachusetts General Hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioimpedance SpectroscopyBIS used to measure fluid in arm | Other | BIS |
Primary outcome
Correlation of Impedance Ratios Obtained Through Bioimpedance Spectroscopy (BIS) With Perometric Relative Arm Volume Change (RVC)
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.
1 secondary outcome
Compare Relationship Between Lymphedema Diagnostic Criteria Corresponding to BIS, Perometry, and Self-reported Symptoms
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34506083Gillespie 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.
- Gillespie 2021 Publication LinkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Impedance Ratios Obtained Through Bioimpedance Spectroscopy (BIS) With Perometric Relative Arm Volume Change (RVC) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01544335, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.