Head and Neck CancerNCT07434245
İnvestigation of the Effect of Neck Endurance on Swallowing and Directional Coordination in Head and Neck Cancer Patients
An observational study of Head and Neck Cancer and Swallowing Disorder, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial summary
In the study, it was aimed to evaluate the relationship between dysphagia, which is one of the treatment complications, and the variables of respiratory performance, intraoral pressure and neck endura, and to look at the future work and rehabilitation methods of these evaluation outcomes from a different parameter. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Cancer, Swallowing Disorder, Respiratory Function
- What is being tested?
- Fiberoptic Endoscopic Evaluate Swallowing
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 1 May 2022
- How long will I take part?
- 1 Day
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients between the ages of 18-80 who were diagnosed with head and neck cancer voluntarily, who met the inclusion criteria and agreed to participate in the study, will be included.
Who may be able to join
- Diagnosing head and neck cancer patients (larynx, nasopharynx, tongue, tonsil, parotid, retromolar trigone, lip, tongue root, hypopharyngeal cancers)
- Statement with consent considering participating in the study
- Disorders that cause obstacles due to the Function Test and intraoral passages
Who cannot join
- Presence of a chronic disease that prevents participation in the pulmonary function test and the study by the radiation oncology doctor and otolaryngologist.
- Patients with swallowing problems due to previous illness or surgery
- Acute surgical patient
Trial locations and contacts
1 site in 1 country.
About this study
In the study, it was aimed to evaluate the relationship between dysphagia, which is one of the treatment complications, and the variables of respiratory performance, intraoral pressure and neck endura, and to look at the future work and rehabilitation methods of these evaluation outcomes from a different parameter.
Read the detailed description
Head and neck cancers; oral cancers, pharyngeal cancers, laryngeal cancers, salivary gland cancers, and cancers involving the skin of the head and neck region. Head and neck cancer treatment options include surgery, radiotherapy, and chemotherapy.
Dysphagia, that is, difficulty in swallowing, is a symptom that affects the quality of life, which is often neglected in patients with head and neck cancer. 40% of patients suffer from dysphagia during and after treatment. Dysphagia causes serious complications such as aspiration, malnutrition and even death, in addition to causing increased health expenditures with a decrease in the quality of life.
Swallowing and respiration are two vital functions coordinated with each other, ensuring coordination is vital.
When the respiratory-swallowing relationship was examined in HNC patients, the patient's breathing was examined through swallowing apnea, but respiratory performance was not evaluated through intraoral pressure and respiratory function test.
Swallowing dysfunctions are frequently seen in patients with head and neck cancer, both due to the pathophysiology of the disease and because the treatments applied due to the localization of the tumor affect the head and neck region, and the quality of life is low because these patients cannot reach rehabilitative approaches. In studies on the effects of chemotherapy and radiotherapy, which are included in the treatment of head and neck cancer patients, it has been proven in the literature that it causes a decrease in swallowing performance and neck endurance over time.
Based on the literature and clinical experience, it can be concluded that there is currently no "gold standard" in the evaluation or treatment of dysphagia in patients with HNC. This result is also valid for the neck endura parameter in patients with head and neck cancer. However, in a study conducted with head and neck cancer patients, it was revealed that there is a correlation between subjective and objective evaluation scales.
At the end of the study, it was aimed to evaluate the relationship between dysphagia, which is one of the treatment complications in patients, with respiratory performance, intraoral pressure and neck endura variables, and to look at the future study and rehabilitation methods from a different parameter.
- Being tested
- Fiberoptic Endoscopic Evaluate Swallowing
- Keywords
- Neck Endurance, Neck ROM, İntraoral Pressure, Respiratory Assessment, Swallowing Assessment, Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms, Deglutition Disorders, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiberoptic Endoscopic Evaluate SwallowingDiagnostic test
Also called Respiratory Function Test, İntraoral Mouth Pressure, Neck Endurance Test, Neck ROM
Our choice in the study consists of subgroups that include Swallowing Assessment, Imaging Assessment and Neck Endurance measurements.
| Study group | Role | What they receive |
|---|---|---|
| Head and Neck Cancer Patients without Swallowing Disorder | This group has 0 between 3 score in EAT-10 Scale. Receives: Diagnostic Test: Fiberoptic Endoscopic Evaluate Swallowing | |
| Head and Neck Cancer Patients with Swallowing Disorder | This group has 4 between 40 score in EAT-10 Scale. Receives: Diagnostic Test: Fiberoptic Endoscopic Evaluate Swallowing |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEES
Fiberoptic Endoscopic Evaluate Parametres ( PAS, Yale Residue Scale, Murray Secretion Scale)
Measured: through study completion, an average of 6 months.
EAT-10 Scale
This scale includes 10 questions.
Measured: through study completion, an average of 6 months.
Neck arthrokinematics assessment
Neck Endurance Test (30s), Neck ROM, Neck Disability İndex
Measured: through study completion, an average of 6 months.
Respiratory Function Test
FEV1, FEV1/FVC, FVC, PEF
Measured: through study completion, an average of 6 months.
İntraoral Mouth Pressure
MIP, MEP
Measured: through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Nov 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Other
- Enrolment
- 28 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Rabia KUM GULER, Istanbul Arel University
- Investigators
- Rabia Kum Güler, PhD(c), PT, Study director, Istanbul Arel U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434245
- Sponsor's protocol ID
- 01
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- İnvestigation of the Effect of Neck Endurance on Swallowing and Directional Coordination in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT07434245
- Acronym / sponsor ID
- 01
- Keywords
- Neck Endurance, Neck ROM, İntraoral Pressure, Respiratory Assessment, Swallowing Assessment, Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Saglik Bilimleri Universitesi
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 25 Feb 2026 (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.
In the study, it was aimed to evaluate the relationship between dysphagia, which is one of the treatment complications, and the variables of respiratory performance, intraoral pressure and neck endura, and to look at the future work and rehabilitation methods of these evaluation outcomes from a different parameter.
Detailed description
Head and neck cancers; oral cancers, pharyngeal cancers, laryngeal cancers, salivary gland cancers, and cancers involving the skin of the head and neck region. Head and neck cancer treatment options include surgery, radiotherapy, and chemotherapy.
Dysphagia, that is, difficulty in swallowing, is a symptom that affects the quality of life, which is often neglected in patients with head and neck cancer. 40% of patients suffer from dysphagia during and after treatment. Dysphagia causes serious complications such as aspiration, malnutrition and even death, in addition to causing increased health expenditures with a decrease in the quality of life.
Swallowing and respiration are two vital functions coordinated with each other, ensuring coordination is vital.
When the respiratory-swallowing relationship was examined in HNC patients, the patient's breathing was examined through swallowing apnea, but respiratory performance was not evaluated through intraoral pressure and respiratory function test.
Swallowing dysfunctions are frequently seen in patients with head and neck cancer, both due to the pathophysiology of the disease and because the treatments applied due to the localization of the tumor affect the head and neck region, and the quality of life is low because these patients cannot reach rehabilitative approaches. In studies on the effects of chemotherapy and radiotherapy, which are included in the treatment of head and neck cancer patients, it has been proven in the literature that it causes a decrease in swallowing performance and neck endurance over time.
Based on the literature and clinical experience, it can be concluded that there is currently no "gold standard" in the evaluation or treatment of dysphagia in patients with HNC. This result is also valid for the neck endura parameter in patients with head and neck cancer. However, in a study conducted with head and neck cancer patients, it was revealed that there is a correlation between subjective and objective evaluation scales.
At the end of the study, it was aimed to evaluate the relationship between dysphagia, which is one of the treatment complications in patients, with respiratory performance, intraoral pressure and neck endura variables, and to look at the future study and rehabilitation methods from a different parameter.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Cancer Patients without Swallowing Disorder | – | Diagnostic Test: Fiberoptic Endoscopic Evaluate SwallowingThis group has 0 between 3 score in EAT-10 Scale. |
| Head and Neck Cancer Patients with Swallowing Disorder | – | Diagnostic Test: Fiberoptic Endoscopic Evaluate SwallowingThis group has 4 between 40 score in EAT-10 Scale. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18-80 who were diagnosed with head and neck cancer voluntarily, who met the inclusion criteria and agreed to participate in the study, will be included.
Key inclusion criteria (3 listed)
- Diagnosing head and neck cancer patients (larynx, nasopharynx, tongue, tonsil, parotid, retromolar trigone, lip, tongue root, hypopharyngeal cancers)
- Statement with consent considering participating in the study
- Disorders that cause obstacles due to the Function Test and intraoral passages
Key exclusion criteria (3 listed)
- Presence of a chronic disease that prevents participation in the pulmonary function test and the study by the radiation oncology doctor and otolaryngologist.
- Patients with swallowing problems due to previous illness or surgery
- Acute surgical patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiberoptic Endoscopic Evaluate SwallowingAlso: Respiratory Function Test, İntraoral Mouth Pressure, Neck Endurance Test, Neck ROMOur choice in the study consists of subgroups that include Swallowing Assessment, Imaging Assessment and Neck Endurance measurements. | Diagnostic test | Head and Neck Cancer Patients with Swallowing Disorder, Head and Neck Cancer Patients without Swallowing Disorder |
Primary outcome
FEES
Time frame: through study completion, an average of 6 months.
Fiberoptic Endoscopic Evaluate Parametres ( PAS, Yale Residue Scale, Murray Secretion Scale)
EAT-10 Scale
Time frame: through study completion, an average of 6 months.
This scale includes 10 questions.
Neck arthrokinematics assessment
Time frame: through study completion, an average of 6 months.
Neck Endurance Test (30s), Neck ROM, Neck Disability İndex
Respiratory Function Test
Time frame: through study completion, an average of 6 months.
FEV1, FEV1/FVC, FVC, PEF
İntraoral Mouth Pressure
Time frame: through study completion, an average of 6 months.
MIP, MEP
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 25 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Rabia Kum Güler, PhD(c), PT study director
Istanbul Arel U
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 Head and Neck Cancer and Swallowing Disorder, run by Istanbul Arel University 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 3 inclusion and 3 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 25 Feb 2026. 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?
FEES (time frame: through study completion, an average of 6 months.). The study lists 5 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 25 Feb 2026.