Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema

Completed

• Conditions: Lymphedema of Upper Arm; Stiffness of Hand, Not Elsewhere Classified; Evaluations, Diagnostic Self
• Interventions: Diagnostic Test: Shear Wave Elastography and B Mode Ultrasonography; Diagnostic Test: Quick Dash Questionnare; Diagnostic Test: The Lymphedema Life Impact Scale; Diagnostic Test: Questioning lymphedema-related symptoms; Other: Extremity circumference and volume measurement

• Registration Number: NCT06009666
• Lead Sponsor: Marmara University

Brief Summary

The aim of this study is to evaluate the feasibility of shear-wave elastography for the diagnosis and staging of breast cancer related lymphedema by assessing the skin and subcutaneous tissues of the arm and forearm, which could serve as a reference standard and be more easily applicable in daily life; and to investigate the relationship between the patients' symptoms and elastographic measurements.

Detailed Description

Both upper extremities of 72 patients with lymphedema and 72 healthy upper extremities were included in the study. The patients' demographic and clinical data were recorded. The thickness and echogenicity of the skin and subcutaneous tissues of all extremities were evaluated with B-mode ultrasonography, and the stiffness of the skin and subcutaneous tissues was evaluated with shear-wave elastography. The lymphedema arm and the healthy arm of the patients were compared both with each other and with the data of the control group. Interobserver and intraobserver reliability analysis was performed for ultrasonography and elastography measurements. The patients' pain, tension, weight, and stiffness symptoms associated with lymphedema were questioned using a numerical scale. The patients' functionality and participation in daily life activities were evaluated with the Quick DASH and Life Impact Index questionnaires. The relationship between these findings and elastographic and ultrasonographic parameters was analyzed.

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-11-01
• Study First Submitted: 2023-02-03
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-20
• Last Update Submitted: 2023-08-20
• Study First Posted: 2023-08-24
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

For the patient group

• between the ages of 18-75
• diagnosed with breast cancer-associated lymphedema by lymphoscintigraphy
• being stage 0-1-2 lymphedema according to ISL staging For the control group
• between the ages of 18-75
• no history of breast cancer

Exclusion Criteria

• History of surgery in the assessment area
• History of trauma at the assessment site
• Active infection in the assessment area
• Presence of congenital or acquired malformations at the assessment site
• Primary lymphedema
• those with any medical condition that may cause edema, such as advanced heart or kidney failure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient Group	The Lymphedema Life Impact Scale	Both Extremities of Patients With Breast Cancer Related Lymphedema
Patient Group	Shear Wave Elastography and B Mode Ultrasonography	Both Extremities of Patients With Breast Cancer Related Lymphedema
Patient Group	Questioning lymphedema-related symptoms	Both Extremities of Patients With Breast Cancer Related Lymphedema
Patient Group	Extremity circumference and volume measurement	Both Extremities of Patients With Breast Cancer Related Lymphedema
Patient Group	Quick Dash Questionnare	Both Extremities of Patients With Breast Cancer Related Lymphedema
Control Group	Shear Wave Elastography and B Mode Ultrasonography	Both Extremities of Healthy People With No History of Breast Cancer

Primary Outcome Measures

Name	Time	Method
B Mode Ultrasonography Measurements	Day 0	Arm and forearm skin and subcutaneous tissue SEG and SEFS grades evaluated in echogenicity grade system by B mode USG
Shear Wave Elastography Measurements	Day 0	Arm and forearm skin and subcutaneous tissue stiffness in kilopascal evaluated by Shear wave elastography

Secondary Outcome Measures

Name	Time	Method
Association of USG and SWE Measurements With Functionality	Day 0	It is the relationship between the parameters evaluated by USG (thickhickness in milimetres , echogenity according to grading system) and SWE (stiffness in kilopascal) and QUİCK DASH Questionnaire Score
Association of USG and SWE Measurements With Symptoms	Day 0	It is the relationship between the parameters evaluated by USG ( thickness in milimetres echogenity according to grading system) and SWE (stiffness in kilopascal) and the pain, tension, heaviness and stiffness scoring in which symptoms in numeric scale.
Association of USG and SWE Measurements With Participation İn Daily Life	Day 0	It is the relationship between the parameters evaluated by USG (thickness in milimetres ,echogenity according to grading system) and SWE (stiffness in kilopascal) and The Life İmpact Questionnaire Scale
Association of USG and SWE Measurements With Volume Measurements	Day 0	It is the volume measurement of both arms of the patients in cubic centimetre.

Trial Locations

Locations (2)

Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation; 🇹🇷 Istanbul, Turkey

Canan Şanal-Toprak; 🇹🇷 İstanbul, Turkey