Evaluation of Swallowing Muscles Using Ultrasonography and Shear Wave Elastography in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma Diagnosis

April 12, 2025 updated by: Fatih İkiz, Konya Beyhekim Training and Research Hospital
The aim of this study is to evaluate the mylohyoid, geniohyoid and digastric muscles in patients with radiotherapy-induced dysphagia due to nasopharynx cancer using ultrasonography and shear wave elastography (SWE).

Study Overview

Status

Completed

Conditions

Detailed Description

Post-radiotherapy swallowing dysfunction evaluation was carried out using fibreoptic endoscopic evaluation (FEES), ultrasonography of the swallowing muscles, shear wave elastography and swallowing assessment scale between the dates of 01/01/2023 and 01/06/2023.

All patients were interviewed to obtain detailed medical histories. Following this, standardized swallowing assessments were administered, including the Eating Assessment Tool (EAT-10) and the M.D. Anderson Dysphagia Inventory (MDADI). Head and neck examination, endoscopic examination and fibreoptic endoscopic swallowing assessment were performed at the Otorhinolaryngology, Head and Neck Surgery clinic. Penetration Aspiration Score (PAS) was determined by the experienced faculty member. Afterwards, an experienced radiologist performed neck ultrasonography and shear wave elastography (SWE) using an Aplio 500 Platinium Ultrasonography system (Toshiba Medical Systems, Japan) equipped with high-frequency linear transducer (frequency range = 5-14 MHz). With SWE, the stiffness values of the mylohyoid, geniohyoid and digastric muscles were measured in m/s and kPa, and their thickness was measured in mm. The tissue elasticity was outlined using a colour-coded system ranging from dark blue indicating least stiffness to red representing greatest stiffness, with a default measurement range of 0-120 kPa. The elastic value E (kPa) is calculated using the equation E = 3 ρ (m/s) 2. In the equation, m/s represents the shear wave propagation speed, and ρ represents the tissue density (approximately 1 in humans). All patients receiving radiotherapy were treated in our hospital's radiation oncology clinic for Stage I nasopharyngeal cancer received 70 Gy (2,12 Gy/Gun) gross tumour value (CTV70), with 5-10 mm margin for microscopic spread, delivered according to the International Commission on Radiation Units and Measurements (ICRU) Reports 50 and 62 guidelines. After obtaining the data, comparisons between the groups and correlations between the quantitative data were assessed using appropriate statistical methods.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42020
        • Selcuk University Faculty of Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

18 or older than 65 years receiving radiotherapy, presented with dysphagia.

Description

Inclusion Criteria

Patient Group:

  • Volunteered for the study.
  • Aged 18-65 years.
  • Diagnosed with Stage I nasopharynx cancer.
  • Completed radiotherapy treatment at least 12 months prior to the study.
  • No additional cancer diagnoses.
  • No history of chemo-radiotherapy.
  • No prior head-neck trauma or surgery.
  • No rheumatologic or neuromuscular disorders.
  • No pre-existing swallowing disorders.
  • Control Group (Healthy Volunteers):

Control group:

  • Aged 18-65 years.
  • No history of head and neck cancer.
  • No prior neck surgery or trauma.
  • No radiotherapy to the head and neck region.
  • No rheumatologic or neuromuscular disorders.
  • No central haemorrhagic or ischemic disease.
  • No pre-existing swallowing disorders.

Exclusion Criterias:

  • Younger than 18 years or older than 65 years.
  • Any history of neck interventions (e.g., for cancer metastasis, cervical spine surgery, trauma).
  • Presence of systemic conditions potentially causing dysphagia (e.g., neurological, rheumatological, metabolic, or muscular disorders).
  • Previous radiotherapy for reasons other than Stage I nasopharynx cancer (in the patient group).
  • Any other cancer diagnosis besides Stage I nasopharynx cancer (in the patient group).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Nasopharynx canser (disease group)
16 Stage I nasopharynx cancer patients receiving radiotherapy
Control (healthy) group
16 healthy volunteers from the otorhinolaryngology outpatient clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Swallowing muscle thickness
Time Frame: 12 months after radiotherapy.
Right and left digastric - mylohyoid muscle thickness, as well as geniohyoid thickness using ultrasonography and Shear Wave Elastography. The thickness values of the mylohyoid, geniohyoid and digastric muscles were measured in mm by experienced radiologist.
12 months after radiotherapy.
Swallowing muscle pressure
Time Frame: 12 months after radiotherapy.
Right and left digastric - mylohyoid muscle pressure, as well as geniohyoid pressure using ultrasonography and Shear Wave Elastography. The outcome pressure is measured in kPA by an experienced radiologist .
12 months after radiotherapy.
Swallowing muscle velocity
Time Frame: 12 months after radiotherapy.
Right and left digastric - mylohyoid muscle velocity, as well as geniohyoid velocity using ultrasonography and Shear Wave Elastography. The velocity values of the mylohyoid, geniohyoid and digastric muscles were measured in m/s by an experienced radiologist.
12 months after radiotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya Beyhekim Training and Research Hospital

Collaborators

Selcuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

April 6, 2025

First Submitted That Met QC Criteria

April 12, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 12, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUFM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

All data generated or analysed during this study are included in this research. Further inquiries or requests regarding the patient data can be directed to the corresponding author when necessary.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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