Status:

RECRUITING

Prospective Screening for Breast Cancer-related Lymphedema

Lead Sponsor:

Massachusetts General Hospital

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lymphedema

Eligibility:

FEMALE

18+ years

Brief Summary

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 ch...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

August 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

10000 Patients enrolled

Trial Details

Trial ID

NCT01521741

Start Date

August 1 2009

End Date

December 1 2026

Last Update

December 24 2025

Active Locations (1)

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1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02134