Prospective Screening for Breast Cancer-related Lymphedema
Recruiting · NCT01521741 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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).
Where it is running
1 location listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States