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NCT Number: NCT07795294

Swallowing Rehabilitation Program for Head and Neck Tumor Patients

This study aims to evaluate the effect of a structured swallowing rehabilitation program on swallowing function, trismus severity, and pain among patients with head and neck tumors, using a randomized controlled trial design. Eighty patients will be randomly allocated into two equal groups: a study group receiving the swallowing rehabilitation program and a control group receiving standard care.

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Key information

Conditions

Head and Neck Cancer (H&N) Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Signs and Symptoms Spasm Trismus

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The swallowing rehabilitation program is a structured intervention designed to improve swallowing ability, mouth opening, and jaw mobility in patients with head and neck tumors. It includes the Mendelsohn maneuver, effortful swallow, Masako technique, tongue strengthening, and jaw range-of-motion and stretching exercises, performed as three sets of ten repetitions twice daily. The program is delivered across four phases (assessment, planning, implementation, and evaluation) over structured orientation, theoretical, and practical sessions. Outcomes are assessed using the EAT-10 (swallowing function) and the Gothenburg Trismus Questionnaire 2 / GTQ2 (trismus severity), in addition to pain level, at baseline and 6 weeks after initiation of the program.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Both genders
  • Aged 20-60 years
  • Patients receiving chemoradiotherapy
  • Patients having a history of head and neck cancer
  • Patients who had received previous radiation therapy for head and neck cancer

Exclusion criteria

  • Patients who had neurological or psychiatric problems
  • Patients who had dysphagia for a reason other than cancer

Treatment and study plan

Swallowing Rehabilitation Program

Behavioral

A structured program including Mendelsohn maneuver, effortful swallow, Masako technique, tongue strengthening exercises, and jaw range-of-motion and stretching exercises, performed as three sets of ten repetitions twice daily, delivered through orientation, theoretical, and practical sessions.

Primary outcomes

  1. Change in Swallowing Function as Measured by the Eating Assessment Tool-10 (EAT-10)

    Time frame: Baseline and 6 weeks after initiation of the swallowing rehabilitation program

    Swallowing function assessed using the Eating Assessment Tool-10 (EAT-10), a 10-item self-administered questionnaire with total scores ranging from 0 to 40, with higher scores indicating greater swallowing difficulty (0-3 = normal swallowing, ≥4 = possible dysphagia, 10-20 = moderate dysphagia, >20 = severe dysphagia).

Secondary outcomes

  1. Change in Trismus Severity as Measured by the Gothenburg Trismus Questionnaire 2 (GTQ-2)

    Time frame: Baseline and 6 weeks after initiation of the swallowing rehabilitation program

    Trismus severity assessed using the Gothenburg Trismus Questionnaire 2 (GTQ-2), a 20-item questionnaire with total scores ranging from 24 to 120, with higher scores indicating greater trismus severity (24 = no trismus, 25-57 = mild, 58-89 = moderate, 90-120 = severe trismus).

Other outcomes

  1. Change in Pain Level as Measured by the Numerical Pain Scale (NPS)

    Time frame: Baseline and 6 weeks after initiation of the swallowing rehabilitation program

    Pain level assessed using the Numerical Pain Scale (NPS), ranging from 0 to 10, with higher scores indicating greater pain severity (0 = none, 1-3 = mild, 4-6 = moderate, 7-10 = severe pain).

Sponsors and collaborators

Lead sponsor

Delta University for Science and Technology

Other

Collaborators

  • Clinical Oncology department. Elmansoura University.
  • National Cancer Institute, Cairo

Registry information

Official study title

Evaluation of a Structured Swallowing Rehabilitation Exercise Program on Dysphagia and Trismus in Head and Neck Tumor Patients

Acronym: SREP-HNC

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 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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