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Prospective Screening for Breast Cancer-related Lymphedema

NCT ID: NCT01521741

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2026-12-31

Brief Summary

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The primary objectives of this study are twofold: 1) to detect and determine the level of symptoms, functional disability, and changes in quality of life that breast cancer patients experience from changes in their arms during and after treatment for breast cancer by collecting patient reported outcome measures, objective measurements, and clinical information in a prospectively maintained database and 2) to improve breast cancer-related lymphedema outcomes by early detection using objective measurements and symptoms assessments and assess these outcomes by maintaining the data in a database in order to contribute to the literature. The secondary aim of this study is to assess extracellular fluid content in the upper extremity, breast, and/or trunk of patients treated for breast cancer before, during, and after treatment in order to better understand the role of bioimpedance spectroscopy in lymphedema screening.

Detailed Description

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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.

Conditions

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Lymphedema

Keywords

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Breast Cancer Lymphedema Symptoms Screening

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast Cancer

Breast Cancer-Related Lymphedema Screening

Intervention Type OTHER

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.

Interventions

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Breast Cancer-Related Lymphedema Screening

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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Alphonse Taghian

Chief of Breast Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alphonse G Taghian, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Alphonse G Taghian, MD PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 22710706 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20605339 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32931555 (View on PubMed)

Other Identifiers

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R01CA139118

Identifier Type: NIH

Identifier Source: secondary_id

View Link

08-540

Identifier Type: -

Identifier Source: org_study_id