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NCT07909538
The Effectiveness of Structured Swallowing Exercise Therapy in Patients With Nasopharyngeal Carcinoma: An Assessment of Swallowing Function and Quality of Life
Conditions: Nasopharyngeal Carcinoma (NPC)
Sex: All
Ages: 18 Years – 59 Years
Healthy volunteers: No
Phase: NA
Enrollment: 88
Sponsor: Ira Mistivani, dr. Sp.KFR.N.M.(K).
Location: RSUPN Dr. Cipto Mangunkusumo (RSCM) Jakarta Pusat DKI Jakarta
Summary
This study aims to evaluate the effectiveness of a structured swallowing exercise program compared with conventional swallowing exercises in patients with nasopharyngeal carcinoma. The study will assess changes in swallowing function, swallowing biomechanics, airway safety, and quality of life following the intervention.
Eligibility Criteria
Inclusion Criteria:
1. Patients with histologically confirmed nasopharyngeal carcinoma.
2. Age 18 to less than 60 years.
3. Male or female.
4. Mini-Mental State Examination (MMSE) score of 25-30.
5. Hemodynamically stable.
6. Non-metastatic nasopharyngeal carcinoma.
7. Gugging Swallowing Screen (GUSS) score of 0-20.
8. Penetration-Aspiration Scale (PAS) score of ≥1 on videofluoroscopic swallowing study (VFSS).
9. Able to undergo VFSS using International Dysphagia Diet Standardisation Initiative (IDDSI) Level 0 and Level 3 consistencies, with or without a nasogastric tube.
10. Willing and able to provide written informed consent.
Exclusion Criteria:
1. History of stroke.
2. Parkinson's disease.
3. Myasthenia gravis.
4. Other head and neck cancer, except nasopharyngeal carcinoma.
5. Esophageal cancer.
6. History of traumatic brain injury.
Source: ClinicalTrials.gov (NCT07909538). StuddyBuddy aggregates publicly available trial information.