Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema

NCT06009666 | Completed

• 1 other identifier: 07.01.2022.145
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• B Mode Ultrasonography Measurements

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

  Day 0

• Shear Wave Elastography Measurements

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

  Day 0

• 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 Outcomes (4)

• Association of USG and SWE Measurements With Symptoms

  Day 0

• Association of USG and SWE Measurements With Functionality

  Day 0

• Association of USG and SWE Measurements With Participation İn Daily Life

  Day 0

• Association of USG and SWE Measurements With Volume Measurements

  Day 0

Study Arms (2)

Patient Group

Both Extremities of Patients With Breast Cancer Related Lymphedema

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

Control Group

Both Extremities of Healthy People With No History of Breast Cancer

Diagnostic Test: Shear Wave Elastography and B Mode Ultrasonography

Interventions

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

Control Group; Patient Group

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.

Patient Group

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.

Patient Group

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.

Patient Group

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.

Patient Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In our study, individuals with breast cancer-related lymphedema diagnosis followed by Marmara University Pendik Training and Research Hospital Physical Medicine and Rehabilitation Department were included in the patient group, while upper extremity data of healthy volunteers without a known lymphedema history were controlled by one-to-one matching, considering the dominant and lymphedema sides of the patient group. included in the group.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (2)

Canan Şanal-Toprak

Istanbul, 34899, Turkey (Türkiye)

Location

Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation

Istanbul, Turkey (Türkiye)

Location

Study Officials

• CANAN ŞANAL TOPRAK

  Marmara University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: August 24, 2023
• Study Start: February 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: November 1, 2022
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

TU (2)