Swallowing Exercises for Nasopharyngeal Cancer After Radiation Therapy

Study Overview
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Brief Summary
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This study is designed to investigate the treatment efficacy of 8 weeks swallowing exercise programs for patients with NPC after radiation therapy. This study also compares two different swallowing exercise: effortful swallow and Mendelsohn's maneuver, to see which one can bring more benefits to patients after a certain period of exercise training. Three assessment tools are selected to evaluate the study result: Mann Assessment of Swallowing Ability (MASA), videofluoroscopic swallowing study (VFSS), and Chinese version Swallowing Quality-of-Life Questionnaire (CSWAL-QOL). The hypothesis of this study is that the effortful swallowing exercise would have better treatment efficacy.

Official Title
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Swallowing Exercises for Patients With Nasopharyngeal Cancer After Radiation Therapy

Conditions
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Nasopharyngeal Cancer, Dysphagia

Intervention / Treatment
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* Other: effortful swallowing exercise
* Other: Mendelsohn swallowing exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients diagnosed with NPC completed radiation therapy at least 1 year mild to moderate swallowing disorder defined by videofluorography able to comply with protocal mandate, willing to perform the exercise programs, and ability to attend the weekly sessions Exclusion Criteria: feeding tube insitu received pharyngeal surgery tracheostomy tube insitu patients who could not put effort to push posterior tongue base backward and who could not elevate their pharyngeal during swallowing severe swallowing disorder or aspirate defined by videofluorography other malignances, neurovascular disease, demyelinating disease cancer relapse or metastases

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: effortful swallowing exercise<br>Subjects in the arm are asked to do the effortful swallowing exercise at home for 8 weeks. The training frequency is to exercise 3-4 days/week, 3 times/day, 10 repetitions per time. Besides the at home exercise, each subject is scheduled to meet the investigator at the hospital at weekly basis to discuss and review his/her exercise practice. | Other: effortful swallowing exercise<br>* voluntarily increases the posterior tongue base pushing effort while swallowing<br>|
| Active Comparator: Mendelsohn swallowing exercise<br>Subjects in the arm are asked to do the Mendelsohn swallowing exercise at home for 8 weeks. The training frequency is to exercise 3-4 days/week, 3 times/day, 10 repetitions per time. Besides the at home exercise, each subject is scheduled to meet the investigator at the hospital at weekly basis to discuss and review his/her exercise practice. | Other: Mendelsohn swallowing exercise<br>* voluntarily increase the extent and duration of laryngeal elevation while swallowing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in videofluoroscopic swallowing study (VFSS) | Videofluoroscopic swallowing study (VFSS) measures the bolus transit time including: 1.oral transit time; 2. pharyngeal transit time; and 3. pharyngeal delay time. It also reveals the occurrence of swallowing aspiration or not. | Change from Baseline in VFSS at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Chinese version of the Swallow Quality-of-Life Questionnaire (CSWAL-QOL) | The Chinese version of SWAL-QOL questionnaire (CSWAL-QOL) contains 10 scales related to swallowing and quality of life, including burden, eating desire, food duration, food selection, communication, fear, mental health, social functioning, sleep, and fatigue. All scales are linearly transformed into a 0-to-100 metric, with 0 indicating most dysfunction and 100 indicating no dysfunction. | Change from Baseline in CSWAL-QOL at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiation, speech-language pathology