Prospective Screening for Breast Cancer-related Lymphedema

ConditionLymphedema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMassachusetts General Hospital

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Breast Cancer-Related Lymphedema Screening

Treatment groups

10,000 Participants
are divided into 1 treatment group

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

National Cancer Institute (NCI)

Collaborator