Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema

NCT06009666 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2023-08-24

No results posted yet for this study

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

Interventions

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

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Principal Investigators

  • CANAN ŞANAL TOPRAK · Marmara University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-04-01
Completion
2022-11-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06009666 on ClinicalTrials.gov