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

NCT06934837 | Completed

• 1 other identifier: SUFM
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

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

Keywords

Dysphagia; Nasopharynx cancer; SWE; Swallowing disorders

Outcome Measures

Primary Outcomes (3)

• Swallowing muscle thickness

  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

  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

  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.

Study Arms (2)

Nasopharynx canser (disease group)

16 Stage I nasopharynx cancer patients receiving radiotherapy

Control (healthy) group

16 healthy volunteers from the otorhinolaryngology outpatient clinic

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Konya Beyhekim Training and Research Hospital: lead
• Selcuk University: collaborator

Study Sites (1)

Selçuk University Faculty of Medicine Hospital

Konya, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Deglutition Disorders; Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 18, 2025
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

TU (1)