Lymphedema Specific PROs for Risk Assessment, Prevention and Early Detection

NCT05929001 | Completed

• 2 other identifiers: 20201038NCI-2021-01490
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Change in Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4) PRO Scores

  Patient reported outcomes (PROs) are a measure of health-related quality of life. The Functional Assessment of Cancer Therapy-Breast (FACT-B+4) will be administered to participants to measure the change in the quality of life after axillary dissection. The FACT-B+4 is a 41-item questionnaire designed to measure six domains of health-related QOL in breast cancer patients: Physical, social, emotional, functional well-being, breast-cancer subscale (BCS) as well as lymphedema subscale. Each response within each domain is scored on a five-point Likert scale ranging from "0" (not at all) to 5 (very much). Higher scores indicate a better quality of life.

  Baseline (pre-operative), postoperative, up to 6 months

• Change in Lymphoedema Functioning, Disability and Health Questionnaire (Lymph-ICF) PRO Scores

  Patient reported outcomes (PROs) are a measure of health-related quality of life. The Lymphoedema Functioning, Disability and Health Questionnaire (Lymph-ICF) will be administered to participants to measure the change in quality of life after axillary dissection. The Lymph ICF is a 29-item questionnaire about impairments in function, activity limitations, and participation restrictions of patients with breast cancer and arm lymphedema. The questionnaire is divided into 5 domains: Physical function, mental function, household activities, mobility activities, and life and social activities. Each response within each domain is scored on a 11-point Likert scale ranging from "0" (not at all) to "10" (a lot). Lower scores indicate a better quality of life.

  Baseline (pre-operative), postoperative, up to 6 months

• Change in Quality of Life Measure for Limb Lymphoedema (LYMQOL) Scores

  The LYMQOL-Arm, primarily as a self-assessment report questionnaire assessing the symptoms of lymphedema in the upper extremity and the ability to perform functional activities in patients with breast cancer-associated lymphedema. There are five subsections in the 21-question survey. These are upper extremity function (questions 1a-h,2,3), appearance (questions 4-8), symptoms (questions 9-14), emotional state (questions 15-20), and general quality of life ( 21st question). In the first 20 questions, there are four options for each question: none (1 point), a little (2 points), quite (3 points), and a lot (4 points). The scores of these subsections are summed up within themselves and divided by the number of questions answered. In the 21st question, the patient is asked to give a value between 0 and 10 for the quality of life. High scores for the first 20 questions and low scores for the 21st question indicate poor quality of life.

  Baseline (pre-operative), up to 6 months

• Change in Lymphedema rate as measured by L-DEX Test

  Lymphedema rate among study participants as measured by the Lymphedema Index Test (L-DEX) and by arm circumference. Lymphedema rate will be reported as the number of participants diagnosed with lymphedema after axillary dissection or radiation. The L-DEX test is a bioimpedance spectroscopy measurement of tissue water content and compares the fluid in a limb at-risk for lymphedema to a healthy limb in order to detect lymphedema.

  Baseline, Up to 6 months

Secondary Outcomes (2)

• Breast Cancer-Related Lymphedema (BCRL) Status: Odds Ratio

  Up to 6 months

• Breast Cancer-Related Lymphedema (BCRL) Status: Area Under the Receiver Operating Characteristic Curve (AUROC)

  Up to 6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients who are scheduled for or who just had axillary dissection at the University of Miami.

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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Eli Avisar, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 3, 2023
• Study Start: January 13, 2021
• Primary Completion: December 31, 2024
• Study Completion: April 15, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)