Structured swallowing exercises for nasopharyngeal cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial compares a structured swallowing exercise program to conventional swallowing exercises in adults with nasopharyngeal carcinoma. Participants are assessed before and after an 8-week intervention for swallowing function, airway safety, biomechanics, and health-related quality of life. Outcomes include GUSS, PAS, hyolaryngeal excursion on videofluoroscopy, and EORTC QLQ-H&N35. The study aims to determine if the structured program provides superior benefits in swallowing safety and function during treatment-related challenges.

Why it matters

Who can join: the full rules

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.

Where it's running

• RSUPN Dr. Cipto Mangunkusumo (RSCM)
  Jakarta Pusat, DKI Jakarta, Indonesia Recruiting

Study contacts

• Principal investigator: Ira Mistivani, Sp.KFR.N.M.(K) — Universitas Indonesia / Faculty of Medicine
• Study coordinator: Ira Mistivani, Sp.KFR.N.M.(K)
• Email: ira.mistivani41@ui.ac.id
• Phone: +62 852 8626 3688

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.