Lymphedema Specific PROs for Risk Assessment, Prevention and Early Detection
Completed
Conditions studied: Lymphedema
In brief
The purpose of this study is to find a way to detect a surgical complication, called lymphedema, at an earlier stage. This potential complication may develop in some patients after removal of the armpit lymph nodes (axillary dissection). It is very important to identify this condition as early as possible to improve the treatment options. This study will examine whether or not focused questionnaires are able to identify lymphedema, comparing to physical measurements (like arm circumference).
Key facts
- Study ID
- NCT05929001
- Run by
- University of Miami
- People needed
- 101
- Starts
- 2021-01-13
- Expected to finish
- 2026-04-15
- Last updated by the study team
- 2026-04-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients 18 years old and older with biopsy-proven breast cancer.
- Scheduled for axillary dissection or probable axillary dissection or within 14 days after axillary dissection at either Jackson Memorial Hospital (JMH) or University of Miami (UM).
- Patients that eventually did not undergo full axillary dissection but had 9 or more lymph nodes removed or received axillary radiation will be allowed to stay in the study.
- Intent to continue follow-up for at least 6 months post-operatively.
- Able to give an informed consent to participate in all study's stages.
- Willing and able to fill questionnaires in person or with assistance at baseline and at 6 months from surgery.
- Bilateral axillary dissection patients are eligible to be enrolled for each side.
You may not qualify if…
- Previous axillary dissection.
- Lymph node biopsy except for biopsies related to the current cancer event.
- Congenital or acquired arm lymphedema.
- Nephrotic Syndrome
- Anasarca
- Unable or unwilling to fill questionnaires at baseline and at 6 months from surgery.
Where it is running
- University of Miami — Miami, Florida, United States
Full record on ClinicalTrials.gov
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