RecruitingNCT01521741

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.


Sponsor

Massachusetts General Hospital

Enrollment

10,000 participants

Start Date

Aug 1, 2009

Study Type

OBSERVATIONAL

Conditions

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 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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is monitoring breast cancer patients before, during, and after treatment to detect lymphedema — a condition where fluid builds up and causes arm swelling — as early as possible, so that it can be treated before it becomes severe. **You may be eligible if...** - You have been diagnosed with breast cancer - You are physically able to hold your shoulder and arm in the required positions for the measurements - You are able to stand without assistance for the measurements **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body in a way that may already be causing swelling - You have had breast cancer before - You already have lymphedema - You are pregnant at the time of enrollment - You have a cardiac (heart) implant such as a pacemaker - You have a medical condition that causes fluid retention or swelling (such as kidney or heart problems) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBreast 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.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT01521741


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