NCT07434245

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2022

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
Last Updated

February 25, 2026

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

May 24, 2022

Last Update Submit

February 20, 2026

Conditions

Keywords

Neck EnduranceNeck ROMİntraoral PressureRespiratory AssessmentSwallowing AssessmentHead and Neck Cancer

Outcome Measures

Primary Outcomes (5)

  • FEES

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

    through study completion, an average of 6 months.

  • EAT-10 Scale

    This scale includes 10 questions.

    through study completion, an average of 6 months.

  • Neck arthrokinematics assessment

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

    through study completion, an average of 6 months.

  • Respiratory Function Test

    FEV1, FEV1/FVC, FVC, PEF

    through study completion, an average of 6 months.

  • İntraoral Mouth Pressure

    MIP, MEP

    through study completion, an average of 6 months.

Study Arms (2)

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

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

Interventions

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

Also known as: Respiratory Function Test, İntraoral Mouth Pressure, Neck Endurance Test, Neck ROM, EAT-10, Neck Disability İndex
Head and Neck Cancer Patients with Swallowing DisorderHead and Neck Cancer Patients without Swallowing Disorder

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Arel University

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsDeglutition DisordersRespiratory Aspiration

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Rabia Kum Güler, PhD(c), PT

    Istanbul Arel U

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Philosophiae Doctor PhD candidate (c)

Study Record Dates

First Submitted

May 24, 2022

First Posted

February 25, 2026

Study Start

November 1, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

February 25, 2026

Record last verified: 2022-05

Locations