Lymphedema Specific PROs for Risk Assessment, Prevention and Early Detection

NCT ID: NCT05929001

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2026-04-30

Brief Summary

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).

Conditions

Lymphedema

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Lymphedema Risk Group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Eli Avisar, MD

Professor of Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eli Avisar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

NCI-2021-01490

Identifier Type: REGISTRY

Identifier Source: secondary_id

20201038

Identifier Type: -

Identifier Source: org_study_id