Prospective Screening for Breast Cancer-related Lymphedema

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT01521741
Status
Recruiting
Apply to this trial

Conditions

  • Lymphedema

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Breast Cancer-Related Lymphedema Screening — 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.

Study Details

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.

Key Dates

Start date
Aug 31, 2009
Status verified
Dec 2025
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
10,000 participants (estimated)

Arms

  • Arm: Breast Cancer

Primary Outcome Measure

Upper extremity changes following treatment for breast cancer [ Time Frame: 1.5 to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02134
Alphonse G Taghian, MD PhD
[email protected]
617-726-6050
Alphonse G Taghian, MD PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MA

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