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Prospective Screening for Breast Cancer-related Lymphedema

RecruitingObservational study

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.

Who can join

Ages 18 and older · Women

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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).

About the study

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.

What is being tested

Sponsor: Massachusetts General Hospital · Participants: 10,000 · Started: 2009-08

Contact the study team

Official record on ClinicalTrials.gov — NCT01521741

Locations in the U.S.

MassachusettsMassachusetts General Hospital, Boston

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.