- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01521741
Prospective Screening for Breast Cancer-related Lymphedema
Prospective Screening for Breast Cancer-related Lymphedema: Analysis of Objective Measurements, Symptoms, Functionality, and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of the study is to create a large, prospectively maintained database with data from multiple objective measurement methods (i.e. perometry and BIS) that has detailed information on patient's symptoms and quality of life measures that can be used to answer research questions.
The study design is prospective in nature, and a questionnaire will be utilized in conjunction with objective measurements before, throughout, and after a patient's treatment for breast cancer. This protocol is designed to mimic the current standard of care screening program with the addition of the quality of life questionnaire and BIS measurements.
Data collection will include medical chart review, perometric arm volume measurements, BIS measurements, and a subjective questionnaire. At their preoperative multidisciplinary breast cancer clinic appointment, patients will undergo baseline arm volume measurements per standard of care. At this time, eligible patients will be offered this study. Those who consent will be given a baseline questionnaire to fill out and have baseline BIS measurements taken. Throughout their treatment and follow-up, patients will periodically have BCRL screening every 2-12 months depending on their risk (i.e. patients who are high risk for BCRL because of extensive lymph node surgery will be measured more often than patients who did not have lymph nodes removed). These screening visits will coincide with naturally occurring oncology follow-up visits; although, patients are also screened when patient or provider requests and questionnaires/BIS measurements will be offered at these time points as well.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02134
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Alphonse G Taghian, MD PhD
- Phone Number: 617-726-6050
- Email: ataghian@partners.org
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Principal Investigator:
- Alphonse G Taghian, MD PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Confirmed diagnosis of breast cancer
- Ability to obtain physical positioning for perometry (e.g. abducting shoulder to 90 degrees) and BIS measurements (e.g. standing without aid)
Exclusion Criteria:
- Evidence of distant metastatic disease that may cause edema,
- Previous breast cancer
- History of lymphedema
- Pregnancy at the time of accrual and/or cardiac implants (contraindications for BIS)
- Medical conditions that cause fluid retention or swelling (e.g. axillary cancer recurrence, renal insufficiency, congestive heart failure).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Breast Cancer
|
All patients enrolled in the trial will receive prospective BCRL screening from their pre-operative baseline throughout their breast cancer treatment process.
All participants will be measured with perometry, bioimpedance spectroscopy, and patient-reported outcome measures.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Upper extremity changes following treatment for breast cancer
Time Frame: 1.5 to 5 years
|
During and following treatment for breast cancer patients' experience a variety of changes in their upper extremities.
The subject responses to the patient-reported outcome measures (BCLE-SEI questionnaire) obtained throughout their breast cancer treatment process will be analyzed in conjunction with arm volume measurements taken with both perometry and bioimpedance spectroscopy.
This will allow for the correlation between quantifiable limb volume changes and subject documented changes in arm use and functionality and quality of life.
|
1.5 to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alphonse G Taghian, MD PhD, Massachusetts General Hospital
Publications and helpful links
General Publications
- Ancukiewicz M, Miller CL, Skolny MN, O'Toole J, Warren LE, Jammallo LS, Specht MC, Taghian AG. Comparison of relative versus absolute arm size change as criteria for quantifying breast cancer-related lymphedema: the flaws in current studies and need for universal methodology. Breast Cancer Res Treat. 2012 Aug;135(1):145-52. doi: 10.1007/s10549-012-2111-8. Epub 2012 Jun 19. Erratum In: Breast Cancer Res Treat. 2012 Nov;136(2):623.
- Ancukiewicz M, Russell TA, Otoole J, Specht M, Singer M, Kelada A, Murphy CD, Pogachar J, Gioioso V, Patel M, Skolny M, Smith BL, Taghian AG. Standardized method for quantification of developing lymphedema in patients treated for breast cancer. Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1436-43. doi: 10.1016/j.ijrobp.2010.01.001. Epub 2010 Jun 3.
- Brunelle CL, Roberts SA, Horick NK, Gillespie TC, Jacobs JM, Daniell KM, Naoum GE, Taghian AG. Integrating Symptoms Into the Diagnostic Criteria for Breast Cancer-Related Lymphedema: Applying Results From a Prospective Surveillance Program. Phys Ther. 2020 Dec 7;100(12):2186-2197. doi: 10.1093/ptj/pzaa162.
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-540
- R01CA139118 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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