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NCT Number: NCT06009666

Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Canan Şanal-Toprak, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shear Wave Elastography and B Mode Ultrasonography

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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.

Extremity circumference and volume measurement

Other

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.

Primary outcomes

  1. B Mode Ultrasonography Measurements

    Time frame: Day 0

    Arm and forearm skin and subcutaneous tissue thicknesses in milimetres evaluated by B mode USG

  2. Shear Wave Elastography Measurements

    Time frame: Day 0

    Arm and forearm skin and subcutaneous tissue stiffness in kilopascal evaluated by Shear wave elastography

  3. B Mode Ultrasonography Measurements

    Time frame: Day 0

    Arm and forearm skin and subcutaneous tissue SEG and SEFS grades evaluated in echogenicity grade system by B mode USG

Secondary outcomes

  1. Association of USG and SWE Measurements With Symptoms

    Time frame: 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.

  2. Association of USG and SWE Measurements With Functionality

    Time frame: 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

  3. Association of USG and SWE Measurements With Participation İn Daily Life

    Time frame: 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

  4. Association of USG and SWE Measurements With Volume Measurements

    Time frame: Day 0

    It is the volume measurement of both arms of the patients in cubic centimetre.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 24, 2023
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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