Recruiting

Prospective Screening for Breast Cancer-related Lymphedema

ClinicalTrials.gov IDNCT01521741

PhaseNot Applicable

Enrollment10000

SponsorMassachusetts General Hospital

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Lymphedema

About this 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.

Interventions

Other: Breast 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.

Primary outcomes

Upper extremity changes following treatment for breast cancer (1.5 to 5 years)

Eligibility information

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).

Study locations

Massachusetts General Hospital, Boston, Massachusetts 02134 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.