Lymphedema Specific PROs for Risk Assessment, Prevention and Early Detection

University of Miami

Status: Active, not recruiting

Conditions: Lymphedema

Study type: Observational

Funder types: Other

Identifiers

NCT05929001

NCI-2021-01490 (Registry Identifier)

20201038

Details and patient eligibility

About

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).

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

101 participants in 1 patient group

Lymphedema Risk Group

Description:

Participants in this group will: 1. Completed questionnaires about daily function and mood, 2. Undergo arm circumference measurement conducted by medical staff, and 3. Undergo Lymphedema Index Test (L-DEX) or measurement of tissue water content, conducted standard of care. Total expected participation is about six months.