An interventional study of Swallowing Rehabilitation Program in Head and Neck Cancer (H&N), sponsored by Delta University for Science and Technology. Recruiting at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Delta University for Science and Technology · Not applicable, Interventional, and Treatment
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.
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 80 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Delta University for Science and Technology is the lead sponsor of 86 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
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
Patients receive routine standard care with no structured rehabilitation program.
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.
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).
Time frame: Baseline and 6 weeks after initiation of the swallowing rehabilitation program
Change in Trismus Severity as Measured by the Gothenburg Trismus Questionnaire 2 (GTQ-2)
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).
Time frame: Baseline and 6 weeks after initiation of the swallowing rehabilitation program
Change in Pain Level as Measured by the Numerical Pain Scale (NPS)
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).
Time frame: Baseline and 6 weeks after initiation of the swallowing rehabilitation program
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Delta University for Science and Technology