Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma DiagnosisNCT06934837
Evaluation of Swallowing Muscles Using Ultrasonography and Shear Wave Elastography in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma Diagnosis
An observational study of Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma Diagnosis and Ultrasonography and Shear Wave Elastography, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma Diagnosis, Ultrasonography and Shear Wave Elastography, Evaluation of Swallowing Muscles
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 18 or older than 65 years receiving radiotherapy, presented with dysphagia.
Who may be able to join
- 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.
Show all 19Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selçuk University Faculty of Medicine Hospital
Konya, 42020
About this study
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).
Read the 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.
- Conditions
- Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma Diagnosis, Ultrasonography and Shear Wave Elastography, Evaluation of Swallowing Muscles
- Keywords
- Dysphagia, Nasopharynx cancer, SWE, Swallowing disorders
- Medical subject headings
- Deglutition Disorders, Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: 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.
Measured: 12 months after radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Jan 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Selcuk University
- Responsible party
- Principal investigator, Fatih İkiz, Konya Beyhekim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934837
- Sponsor's protocol ID
- SUFM
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Swallowing Muscles Using Ultrasonography and Shear Wave Elastography in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma Diagnosis
- ClinicalTrials.gov ID
- NCT06934837
- Acronym / sponsor ID
- SUFM
- Conditions
- Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma Diagnosis, Ultrasonography and Shear Wave Elastography, Evaluation of Swallowing Muscles
- Keywords
- Dysphagia, Nasopharynx cancer, SWE, Swallowing disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Collaborators
- Selcuk University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasopharynx canser (disease group) | – | –16 Stage I nasopharynx cancer patients receiving radiotherapy |
| Control (healthy) group | – | –16 healthy volunteers from the otorhinolaryngology outpatient clinic |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18 or older than 65 years receiving radiotherapy, presented with dysphagia.
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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 .
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma Diagnosis and Ultrasonography and Shear Wave Elastography, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing muscle thickness (time frame: 12 months after radiotherapy.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.