Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema

Lymphedema of Upper Arm Clinical Trial

Official title:

Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema and Investigation of the Relationship of These Parameters With Clinical Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06009666
• Other study ID #: 07.01.2022.145
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: August 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Evaluations, Diagnostic Self
• Lymphedema
• Lymphedema of Upper Arm
• Stiffness of Hand, Not Elsewhere Classified

Intervention

Diagnostic Test:
• Shear Wave Elastography and B Mode Ultrasonography
We evaluated the both upper extremities of the patient and control group with elastography and B mode ultrasonography. Shear wave elastography evaluates tissue deformation caused by acoustic radiation force. A highly focused ultrasound radiation is produced; The propagation speed of the shear wave depends on the stiffness of the tissue. It is a simple, inexpensive, bedside, widely available, non-invasive technique. B mode USG can be used to assess skin and subcutaneous tissue thickness and echogenicity. Skin and subcutaneous thickness were measured with b mode ultrasound. Skin and subcutaneous tissue stiffness was measured by shear wave ultrasonography
• Quick Dash Questionnare
Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. In the questionnaire, the difficulties of the patients during their daily living activities are questioned with 11 questions. Each answer is scored from 1 to 5 on a Likert scale, from best to worst.
• The Lymphedema Life Impact Scale
The Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 functional subgroups. Each question is scored from 1 to 5, with higher scores indicating increased seriousness.
• Questioning lymphedema-related symptoms
Arm pain and feeling of tension, heaviness and stiffness in the arm were evaluated separately by numerical scale. This scale is a 10 cm ruler that writes no pain, no tension, no heaviness, no stiffness on one side, and unbearable pain, tension and heaviness on the other side. Patients were asked to rate their associated symptoms on this scale between 0 and 10.

Other:
• Extremity circumference and volume measurement
For the diagnosis of lymphedema, a detailed physical examination and extremity circumference were measured. This measurement was taken from both wrists to arm height with 4 cm intervals. Those with a circumference difference greater than 2 cm and/or no 10% volume difference were considered preclinical (latent) and those with clinical lymphedema.

Locations

Country	Name	City	State
Turkey	Canan Sanal-Toprak	Istanbul
Turkey	Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	B Mode Ultrasonography Measurements	Arm and forearm skin and subcutaneous tissue thicknesses in milimetres evaluated by B mode USG	Day 0
Primary	Shear Wave Elastography Measurements	Arm and forearm skin and subcutaneous tissue stiffness in kilopascal evaluated by Shear wave elastography	Day 0
Primary	B Mode Ultrasonography Measurements	Arm and forearm skin and subcutaneous tissue SEG and SEFS grades evaluated in echogenicity grade system by B mode USG	Day 0
Secondary	Association of USG and SWE Measurements With Symptoms	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.	Day 0
Secondary	Association of USG and SWE Measurements With Functionality	It is the relationship between the parameters evaluated by USG (thickhickness in milimetres , echogenity according to grading system) and SWE (stiffness in kilopascal) and QUICK DASH Questionnaire Score	Day 0
Secondary	Association of USG and SWE Measurements With Participation In Daily Life	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 Impact Questionnaire Scale	Day 0
Secondary	Association of USG and SWE Measurements With Volume Measurements	It is the volume measurement of both arms of the patients in cubic centimetre.	Day 0