An interventional study of Structured Swallowing Exercise and Conventional Swallowing Exercise in Nasopharyngeal Carcinoma (NPC), sponsored by Ira Mistivani, dr. Sp.KFR.N.M.(K).. Recruiting at 1 site in Indonesia. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Ira Mistivani, dr. Sp.KFR.N.M.(K). · Not applicable, Interventional, and Treatment
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.
Nasopharyngeal carcinoma is associated with swallowing dysfunction, which may affect swallowing safety, swallowing biomechanics, nutritional status, and quality of life. Early swallowing rehabilitation or prehabilitation may help maintain and improve swallowing function during cancer treatment.
This study is a randomized controlled trial designed to evaluate the effectiveness of a structured swallowing exercise program compared with conventional swallowing exercises in patients with nasopharyngeal carcinoma.
Eligible participants will be randomly assigned to either the structured swallowing exercise group or the conventional swallowing exercise group. The intervention will be conducted for 8 weeks.
Swallowing function will be evaluated using the Gugging Swallowing Screen (GUSS), penetration-aspiration scale (PAS), and videofluoroscopic swallowing study (VFSS). Hyolaryngeal excursion will be assessed using VFSS analysis. Health-related quality of life related to head and neck symptoms and swallowing will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Module 35 (EORTC QLQ-H\&N35).
GUSS will be assessed at baseline, week 4, and week 8. PAS, hyolaryngeal excursion, and EORTC QLQ-H\&N35 will be assessed at baseline and at week 8. The study will compare changes in swallowing function, swallowing biomechanics, airway safety, and quality of life between the two intervention groups.
683 studies on the registry are indexed under Nasopharyngeal Carcinoma; 270 are open to participants now.
This study's planned enrollment of 88 is below the median of 100 across 557 interventional studies indexed under Nasopharyngeal Carcinoma.
Browse Nasopharyngeal Carcinoma studies →This is the only study on the registry with Ira Mistivani, dr. Sp.KFR.N.M.(K). as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will receive a conventional swallowing exercise program for 8 weeks. The program consists of conventional swallowing rehabilitation exercises aimed at maintaining and improving swallowing function and swallowing biomechanics in patients with nasopharyngeal carcinoma.
Behavioral: Conventional Swallowing Exercise
Participants randomized to this arm will receive a structured swallowing exercise program for 8 weeks. The program is designed as a structured swallowing rehabilitation intervention to maintain and improve swallowing function, swallowing biomechanics, airway safety, and swallowing-related quality of life in patients with nasopharyngeal carcinoma.
Behavioral: Structured Swallowing Exercise
The structured swallowing exercise program is a multimodal, systematic, and progressive swallowing rehabilitation program consisting of Isometric Neck Flexion-Extension Exercise, Jaw Opening Exercise, Jaw Range of Motion Exercise, Tongue Range of Motion Exercise, Chin Tuck Against Resistance (CTAR), Mendelsohn Maneuver, and Diaphragmatic Breathing Exercise. The exercises are organized progressively into preparation, strengthening, coordination, and functional phases. The program is delivered for 30 minutes per session, twice weekly at the hospital for 8 weeks, with additional home exercises three times weekly. Individual modifications may be made according to the participant's clinical condition, and adherence is monitored through an exercise logbook and periodic supervision.
The conventional swallowing exercise program consists of Chin Tuck Against Resistance (CTAR) and Isometric Neck Flexion-Extension Exercise, primarily targeting suprahyoid and anterior cervical muscle strengthening and hyolaryngeal excursion. CTAR includes 3 cycles of 60-second isometric exercise and 2 cycles of 30 repetitions of isotonic exercise, repeated for 3 sets per day. Isometric Neck Flexion-Extension Exercise consists of resisted neck flexion and extension, with each contraction maintained for 5-10 seconds, performed in 3 sets per day with 10-15 repetitions per set. The program is delivered for 30 minutes per session, twice weekly at the hospital for 8 weeks, with additional home exercises three times weekly. Adherence is monitored during the study.
Change in Hyolaryngeal Excursion from Baseline to Week 8
Hyolaryngeal excursion (HLE) assessed during VFSS by frame-by-frame analysis of hyoid bone displacement during swallowing. HLE is calculated from the anterior and superior displacement of the hyoid bone between its resting position and maximal elevation during swallowing and expressed in millimeters (mm). The outcome will be assessed as the change in HLE from baseline to week 8, with greater excursion indicating greater hyolaryngeal movement.
Time frame: Baseline and Week 8
Change in Penetration-Aspiration Scale (PAS) Score from Baseline to Week 8
Penetration-Aspiration Scale (PAS) score assessed during videofluoroscopic swallowing study (VFSS) to evaluate airway penetration and aspiration during swallowing. The PAS is an 8-point scale, ranging from 1 to 8, with higher scores indicating more severe airway invasion. The outcome will be assessed as the change in PAS score from baseline to week 8.
Time frame: Baseline and Week 8
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 (EORTC QLQ-H&N35) Score from Baseline to Week 8
Health-related quality of life assessed using the validated Indonesian version of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 (EORTC QLQ-H\&N35). The questionnaire assesses symptoms and problems related to head and neck cancer, including swallowing, eating, social contact, dry mouth, thick saliva, pain, speech, and other disease- or treatment-related symptoms. Scores are transformed to a 0-100 scale, with higher scores indicating greater symptom burden or problems and therefore worse symptom-related quality of life. The outcome will be assessed as the change in score from baseline to week 8.
Time frame: Baseline and Week 8
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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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