Swallowing Rehabilitation Program for Head and Neck Tumor Patients

NCT07795294 | Not Yet Recruiting

• 1 other identifier: MU-Nurs-HNC-1249
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer (H&N)

Keywords

Dysphagia; Trismus; Swallowing Rehabilitation; Deglutition Disorders; Head and Neck Cancer; EAT-10; Gothenburg Trismus Questionnaire

Outcome Measures

Primary Outcomes (1)

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

  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).

  Baseline and 6 weeks after initiation of the swallowing rehabilitation program

Secondary Outcomes (1)

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

  Baseline and 6 weeks after initiation of the swallowing rehabilitation program

Other Outcomes (1)

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

  Baseline and 6 weeks after initiation of the swallowing rehabilitation program

Study Arms (2)

Swallowing Rehabilitation Program

EXPERIMENTAL

Participants will receive a structured swallowing rehabilitation program including Mendelsohn maneuver, effortful swallow, Masako technique, tongue strengthening exercises, and jaw range-of-motion and stretching exercises. Exercises will be performed as three sets of ten repetitions, twice daily, delivered across orientation, theoretical, and practical sessions over four phases (assessment, planning, implementation, evaluation).

Behavioral: Swallowing Rehabilitation Program

Standard Care

NO INTERVENTION

Patients receive routine standard care with no structured rehabilitation program.

Interventions

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.

Swallowing Rehabilitation Program

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Delta University for Science and Technology: lead
• National Cancer Institute, Cairo: collaborator
• Clinical Oncology department. Elmansoura University.: collaborator

Study Sites (1)

National Cancer Institute, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Deglutition Disorders; Trismus

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 31, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): June 25, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)