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

Lymphedema

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

Inclusion Criteria2

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 Criteria5

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).

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.