Nasopharyngeal Carcinoma (NPC)NCT07909538
The Effectiveness of Structured Swallowing Exercise Therapy in Patients With Nasopharyngeal Carcinoma: An Assessment of Swallowing Function and Quality of Life
A study testing Structured Swallowing Exercise and Conventional Swallowing Exercise in people with Nasopharyngeal Carcinoma (NPC), run by Ira Mistivani, dr. Sp.KFR.N.M.(K). at 1 site in Indonesia.
Trial summary
This study aims to evaluate the effectiveness of a structured swallowing exercise program compared with conventional swallowing exercises in patients with nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Structured Swallowing Exercise and Conventional Swallowing Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteIndonesia
- Study dates
- 9 Sep 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with histologically confirmed nasopharyngeal carcinoma.
- Age 18 to less than 60 years.
- Male or female.
- Mini-Mental State Examination (MMSE) score of 25-30.
- Hemodynamically stable.
- Non-metastatic nasopharyngeal carcinoma.
Show all 10Show fewer
- Gugging Swallowing Screen (GUSS) score of 0-20.
- Penetration-Aspiration Scale (PAS) score of ≥1 on videofluoroscopic swallowing study (VFSS).
- Able to undergo VFSS using International Dysphagia Diet Standardisation Initiative (IDDSI) Level 0 and Level 3 consistencies, with or without a nasogastric tube.
- Willing and able to provide written informed consent.
Who cannot join
- History of stroke.
- Parkinson's disease.
- Myasthenia gravis.
- Other head and neck cancer, except nasopharyngeal carcinoma.
- Esophageal cancer.
- History of traumatic brain injury.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
RSUPN Dr. Cipto Mangunkusumo (RSCM)
Jakarta Pusat, DKI Jakarta
Ira Mistivani, Sp.KFR.N.M.(K), +62 852 8626 3688, ira.mistivani41@ui.ac.id
Ira Mistivani, Sp.KFR.N.M.(K)
About this study
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.
Read the detailed description
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.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Structured Swallowing Exercise, Conventional Swallowing Exercise
- Keywords
- Nasopharyngeal Carcinoma, Dysphagia, Swallowing rehabilitation, Swallowing exercise, Swallowing function, Videofluoroscopic swallowing study, Hyolaryngeal excursion, Quality of life
- Medical subject headings
- Nasopharyngeal Carcinoma, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Swallowing ExerciseBehavioural
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.
Conventional Swallowing ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Swallowing Exercise | Active comparator | 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. Receives: Behavioral: Conventional Swallowing Exercise |
| Structured Swallowing Exercise | Experimental | 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. Receives: Behavioral: Structured Swallowing Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start9 Sep 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ira Mistivani, dr. Sp.KFR.N.M.(K).
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital
- Responsible party
- Sponsor-investigator, Ira Mistivani, dr. Sp.KFR.N.M.(K)., Universitas Indonesia
- Investigators
- Ira Mistivani, Sp.KFR.N.M.(K), Principal investigator, Universitas Indonesia / Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909538
- Sponsor's protocol ID
- 26-07-1181
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rahmaeni R; Kuhuwael F; Rahardjo SP; Validitas dan reliabilitas EORTC QLQ-H&N35 sebagai alat ukur kualitas hidup penderita kanker kepala leher; Oto Rhino Laryngologica Indonesiana; December 2015; 45(2); 142-150.
Logemann JA, Pauloski BR, Rademaker AW, Colangelo LA. Speech and swallowing rehabilitation for head and neck cancer patients. Oncology (Williston Park). 1997 May;11(5):651-6, 659; discussion 659, 663-4.
PubMed 9159792McCullough GH, Kim Y. Effects of the Mendelsohn maneuver on extent of hyoid movement and UES opening post-stroke. Dysphagia. 2013 Dec;28(4):511-9. doi: 10.1007/s00455-013-9461-1. Epub 2013 Mar 14.
PubMed 23494471Kraaijenga SAC, Molen LV, Stuiver MM, Takes RP, Al-Mamgani A, Brekel MWMVD, Hilgers FJM. Efficacy of a novel swallowing exercise program for chronic dysphagia in long-term head and neck cancer survivors. Head Neck. 2017 Oct;39(10):1943-1961. doi: 10.1002/hed.24710. Epub 2017 Aug 2.
PubMed 28766850Yoon WL, Khoo JK, Rickard Liow SJ. Chin tuck against resistance (CTAR): new method for enhancing suprahyoid muscle activity using a Shaker-type exercise. Dysphagia. 2014 Apr;29(2):243-8. doi: 10.1007/s00455-013-9502-9. Epub 2013 Dec 15.
PubMed 24337867Brates D, Molfenter SM, Thibeault SL. Assessing Hyolaryngeal Excursion: Comparing Quantitative Methods to Palpation at the Bedside and Visualization During Videofluoroscopy. Dysphagia. 2019 Jun;34(3):298-307. doi: 10.1007/s00455-018-9927-2. Epub 2018 Jul 24.
PubMed 30043080Sia I, Carvajal P, Carnaby-Mann GD, Crary MA. Measurement of hyoid and laryngeal displacement in video fluoroscopic swallowing studies: variability, reliability, and measurement error. Dysphagia. 2012 Jun;27(2):192-7. doi: 10.1007/s00455-011-9352-2. Epub 2011 Jul 7.
PubMed 21735182Alkhuwaiter M, Davidson K, Hopkins-Rossabi T, Martin-Harris B. Scoring the Penetration-Aspiration Scale (PAS) in Two Conditions: A Reliability Study. Dysphagia. 2022 Apr;37(2):407-416. doi: 10.1007/s00455-021-10292-6. Epub 2021 Apr 21.
PubMed 33880656Cengiz M, Ozyar E, Esassolak M, Altun M, Akmansu M, Sen M, Uzel O, Yavuz A, Dalmaz G, Uzal C, Hicsonmez A, Sarihan S, Kaplan B, Atasoy BM, Ulutin C, Abacioglu U, Demiral AN, Hayran M. Assessment of quality of life of nasopharyngeal carcinoma patients with EORTC QLQ-C30 and H&N-35 modules. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1347-53. doi: 10.1016/j.ijrobp.2005.05.057. Epub 2005 Sep 19.
PubMed 16169671Baudelet M, Van den Steen L, Duprez F, Goeleven A, Nuyts S, Nevens D, Vandenbruaene C, Massonet H, Vergauwen A, Vauterin T, Verstraete H, Wouters K, Vanderveken O, De Bodt M, Van Nuffelen G; members of the Belgian PRESTO-group. Prophylactic Swallowing Therapy During Head-and-Neck Cancer Radiotherapy: Effect of Service-Delivery Mode and Overall Adherence Level on Swallowing Function and Muscle Strength-the PRESTO Trial. Dysphagia. 2024 Apr;39(2):267-281. doi: 10.1007/s00455-023-10609-7. Epub 2023 Aug 8.
PubMed 37550571Hajdu SF, Wessel I, Dalton SO, Eskildsen SJ, Johansen C. Swallowing Exercise During Head and Neck Cancer Treatment: Results of a Randomized Trial. Dysphagia. 2022 Aug;37(4):749-762. doi: 10.1007/s00455-021-10320-5. Epub 2021 Jun 11.
PubMed 34117531Ku PKM, Vlantis AC, Wong RWM, Hui TSC, Law T, Ng LKY, Wong EWY, Chang WT, Johnson DR, Mok FST, Wong KH, Abdullah V, van Hasselt A, Lee KYS, Tong MCF. Quality of life and swallowing outcomes after early proactive swallowing rehabilitation by either transcutaneous neuromuscular electrical stimulation or exercise-based swallowing training in patients with nasopharyngeal carcinoma after radiotherapy. Laryngoscope Investig Otolaryngol. 2023 Oct 14;8(6):1532-1546. doi: 10.1002/lio2.1162. eCollection 2023 Dec.
PubMed 38130249
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Structured Swallowing Exercise Therapy in Patients With Nasopharyngeal Carcinoma: An Assessment of Swallowing Function and Quality of Life
- ClinicalTrials.gov ID
- NCT07909538
- Acronym / sponsor ID
- 26-07-1181
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- Nasopharyngeal Carcinoma, Dysphagia, Swallowing rehabilitation, Swallowing exercise, Swallowing function, Videofluoroscopic swallowing study, Hyolaryngeal excursion, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Ira Mistivani, dr. Sp.KFR.N.M.(K).University, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Swallowing Exercise | Active comparator | Behavioral: Conventional Swallowing ExerciseParticipants 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. |
| Structured Swallowing Exercise | Experimental | Behavioral: Structured Swallowing ExerciseParticipants 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients with histologically confirmed nasopharyngeal carcinoma.
- Age 18 to less than 60 years.
- Male or female.
- Mini-Mental State Examination (MMSE) score of 25-30.
- Hemodynamically stable.
Key exclusion criteria (6 listed)
- History of stroke.
- Parkinson's disease.
- Myasthenia gravis.
- Other head and neck cancer, except nasopharyngeal carcinoma.
- Esophageal cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Swallowing ExerciseThe 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. | Behavioural | Structured Swallowing Exercise |
| Conventional Swallowing ExerciseThe 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. | Behavioural | Conventional Swallowing Exercise |
Primary outcome
Change in Hyolaryngeal Excursion from Baseline to Week 8
Time frame: Baseline and 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.
Change in Penetration-Aspiration Scale (PAS) Score from Baseline to Week 8
Time frame: Baseline and 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.
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
Time frame: Baseline and 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- BackgroundRahmaeni R; Kuhuwael F; Rahardjo SP; Validitas dan reliabilitas EORTC QLQ-H&N35 sebagai alat ukur kualitas hidup penderita kanker kepala leher; Oto Rhino Laryngologica Indonesiana; December 2015; 45(2); 142-150.
- Background: PubMed 9159792Logemann JA, Pauloski BR, Rademaker AW, Colangelo LA. Speech and swallowing rehabilitation for head and neck cancer patients. Oncology (Williston Park). 1997 May;11(5):651-6, 659; discussion 659, 663-4.
- Background: PubMed 23494471McCullough GH, Kim Y. Effects of the Mendelsohn maneuver on extent of hyoid movement and UES opening post-stroke. Dysphagia. 2013 Dec;28(4):511-9. doi: 10.1007/s00455-013-9461-1. Epub 2013 Mar 14.
- Background: PubMed 28766850Kraaijenga SAC, Molen LV, Stuiver MM, Takes RP, Al-Mamgani A, Brekel MWMVD, Hilgers FJM. Efficacy of a novel swallowing exercise program for chronic dysphagia in long-term head and neck cancer survivors. Head Neck. 2017 Oct;39(10):1943-1961. doi: 10.1002/hed.24710. Epub 2017 Aug 2.
- Background: PubMed 24337867Yoon WL, Khoo JK, Rickard Liow SJ. Chin tuck against resistance (CTAR): new method for enhancing suprahyoid muscle activity using a Shaker-type exercise. Dysphagia. 2014 Apr;29(2):243-8. doi: 10.1007/s00455-013-9502-9. Epub 2013 Dec 15.
- Background: PubMed 30043080Brates D, Molfenter SM, Thibeault SL. Assessing Hyolaryngeal Excursion: Comparing Quantitative Methods to Palpation at the Bedside and Visualization During Videofluoroscopy. Dysphagia. 2019 Jun;34(3):298-307. doi: 10.1007/s00455-018-9927-2. Epub 2018 Jul 24.
- Background: PubMed 21735182Sia I, Carvajal P, Carnaby-Mann GD, Crary MA. Measurement of hyoid and laryngeal displacement in video fluoroscopic swallowing studies: variability, reliability, and measurement error. Dysphagia. 2012 Jun;27(2):192-7. doi: 10.1007/s00455-011-9352-2. Epub 2011 Jul 7.
- Background: PubMed 33880656Alkhuwaiter M, Davidson K, Hopkins-Rossabi T, Martin-Harris B. Scoring the Penetration-Aspiration Scale (PAS) in Two Conditions: A Reliability Study. Dysphagia. 2022 Apr;37(2):407-416. doi: 10.1007/s00455-021-10292-6. Epub 2021 Apr 21.
- Background: PubMed 16169671Cengiz M, Ozyar E, Esassolak M, Altun M, Akmansu M, Sen M, Uzel O, Yavuz A, Dalmaz G, Uzal C, Hicsonmez A, Sarihan S, Kaplan B, Atasoy BM, Ulutin C, Abacioglu U, Demiral AN, Hayran M. Assessment of quality of life of nasopharyngeal carcinoma patients with EORTC QLQ-C30 and H&N-35 modules. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1347-53. doi: 10.1016/j.ijrobp.2005.05.057. Epub 2005 Sep 19.
- Background: PubMed 37550571Baudelet M, Van den Steen L, Duprez F, Goeleven A, Nuyts S, Nevens D, Vandenbruaene C, Massonet H, Vergauwen A, Vauterin T, Verstraete H, Wouters K, Vanderveken O, De Bodt M, Van Nuffelen G; members of the Belgian PRESTO-group. Prophylactic Swallowing Therapy During Head-and-Neck Cancer Radiotherapy: Effect of Service-Delivery Mode and Overall Adherence Level on Swallowing Function and Muscle Strength-the PRESTO Trial. Dysphagia. 2024 Apr;39(2):267-281. doi: 10.1007/s00455-023-10609-7. Epub 2023 Aug 8.
- Background: PubMed 34117531Hajdu SF, Wessel I, Dalton SO, Eskildsen SJ, Johansen C. Swallowing Exercise During Head and Neck Cancer Treatment: Results of a Randomized Trial. Dysphagia. 2022 Aug;37(4):749-762. doi: 10.1007/s00455-021-10320-5. Epub 2021 Jun 11.
- Background: PubMed 38130249Ku PKM, Vlantis AC, Wong RWM, Hui TSC, Law T, Ng LKY, Wong EWY, Chang WT, Johnson DR, Mok FST, Wong KH, Abdullah V, van Hasselt A, Lee KYS, Tong MCF. Quality of life and swallowing outcomes after early proactive swallowing rehabilitation by either transcutaneous neuromuscular electrical stimulation or exercise-based swallowing training in patients with nasopharyngeal carcinoma after radiotherapy. Laryngoscope Investig Otolaryngol. 2023 Oct 14;8(6):1532-1546. doi: 10.1002/lio2.1162. eCollection 2023 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ira Mistivani, Sp.KFR.N.M.(K) principal investigator
Universitas Indonesia / Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Swallowing Exercise and Conventional Swallowing Exercise in people with Nasopharyngeal Carcinoma (NPC), run by Ira Mistivani, dr. Sp.KFR.N.M.(K). at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ira Mistivani, Sp.KFR.N.M.(K) (+62 852 8626 3688, ira.mistivani41@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hyolaryngeal Excursion from Baseline to Week 8 (time frame: Baseline and Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07909538, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.