İnvestigation of the Effect of Neck Endurance on Swallowing and Directional Coordination in Head and Neck Cancer Patients

February 20, 2026 updated by: Rabia KUM GULER, Istanbul Arel University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

28

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 (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye)
        • Istanbul Arel University

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

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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
Intervention / Treatment
Head and Neck Cancer Patients without Swallowing Disorder
This group has 0 between 3 score in EAT-10 Scale.
Diagnostic test: Fiberoptic Endoscopic Evaluate Swallowing
Our choice in the study consists of subgroups that include Swallowing Assessment, Imaging Assessment and Neck Endurance measurements.
Other Names:
  • EAT-10
  • Respiratory Function Test
  • Neck Disability İndex
  • İntraoral Mouth Pressure
  • Neck Endurance Test
  • Neck ROM
Head and Neck Cancer Patients with Swallowing Disorder
This group has 4 between 40 score in EAT-10 Scale.
Diagnostic test: Fiberoptic Endoscopic Evaluate Swallowing
Our choice in the study consists of subgroups that include Swallowing Assessment, Imaging Assessment and Neck Endurance measurements.
Other Names:
  • EAT-10
  • Respiratory Function Test
  • Neck Disability İndex
  • İntraoral Mouth Pressure
  • Neck Endurance Test
  • Neck ROM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEES
Time Frame: through study completion, an average of 6 months.
Fiberoptic Endoscopic Evaluate Parametres ( PAS, Yale Residue Scale, Murray Secretion Scale)
through study completion, an average of 6 months.
EAT-10 Scale
Time Frame: through study completion, an average of 6 months.
This scale includes 10 questions.
through study completion, an average of 6 months.
Neck arthrokinematics assessment
Time Frame: through study completion, an average of 6 months.
Neck Endurance Test (30s), Neck ROM, Neck Disability İndex
through study completion, an average of 6 months.
Respiratory Function Test
Time Frame: through study completion, an average of 6 months.
FEV1, FEV1/FVC, FVC, PEF
through study completion, an average of 6 months.
İntraoral Mouth Pressure
Time Frame: through study completion, an average of 6 months.
MIP, MEP
through study completion, an average of 6 months.

Collaborators and Investigators

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

Sponsor

Istanbul Arel University

Collaborators

Saglik Bilimleri Universitesi
The Scientific and Technological Research Council of Turkey

Investigators

  • Study Director: Rabia KUM GÜLER, PhD(c), PT, Istanbul Arel U

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)

November 1, 2021

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

May 24, 2022

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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