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Completed

NCT Number: NCT07434245

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fiberoptic Endoscopic Evaluate Swallowing

Diagnostic Test

Our choice in the study consists of subgroups that include Swallowing Assessment, Imaging Assessment and Neck Endurance measurements.

Other names: Respiratory Function Test, İntraoral Mouth Pressure, Neck Endurance Test, Neck ROM, EAT-10, Neck Disability İndex

Primary outcomes

  1. FEES

    Time frame: through study completion, an average of 6 months.

    Fiberoptic Endoscopic Evaluate Parametres ( PAS, Yale Residue Scale, Murray Secretion Scale)

  2. EAT-10 Scale

    Time frame: through study completion, an average of 6 months.

    This scale includes 10 questions.

  3. Neck arthrokinematics assessment

    Time frame: through study completion, an average of 6 months.

    Neck Endurance Test (30s), Neck ROM, Neck Disability İndex

  4. Respiratory Function Test

    Time frame: through study completion, an average of 6 months.

    FEV1, FEV1/FVC, FVC, PEF

  5. İntraoral Mouth Pressure

    Time frame: through study completion, an average of 6 months.

    MIP, MEP

Sponsors and collaborators

Lead sponsor

Istanbul Arel University

Other

Collaborators

  • Saglik Bilimleri Universitesi
  • The Scientific and Technological Research Council of Turkey

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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