Actively Recruiting

Age: 18Years +
FEMALE
NCT01521741

Prospective Screening for Breast Cancer-related Lymphedema

Led by Massachusetts General Hospital · Updated on 2025-12-24

10000

Participants Needed

1

Research Sites

904 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prospective Screening for Breast Cancer-related Lymphedema

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of breast cancer
  • Ability to position arm for perometry measurements (e.g., shoulder abducted to 90 degrees)
  • Ability to stand unaided for bioimpedance spectroscopy (BIS) measurements
Not Eligible

You will not qualify if you...

  • Evidence of distant metastatic disease causing edema
  • Previous breast cancer
  • History of lymphedema
  • Pregnancy at time of enrollment
  • Presence of cardiac implants (contraindications for BIS)
  • Medical conditions causing fluid retention or swelling (e.g., axillary cancer recurrence, renal insufficiency, congestive heart failure)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02134

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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