Dysphagia, Nasopharyngeal Cancer
Conditions
Keywords
radiation, speech-language pathology
Brief summary
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.
Interventions
OTHEReffortful swallowing exercise
voluntarily increases the posterior tongue base pushing effort while swallowing
OTHERMendelsohn swallowing exercise
voluntarily increase the extent and duration of laryngeal elevation while swallowing
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in videofluoroscopic swallowing study (VFSS) | Change from Baseline in VFSS at 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Chinese version of the Swallow Quality-of-Life Questionnaire (CSWAL-QOL) | Change from Baseline in CSWAL-QOL at 8 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Mann Assessment of Swallowing Ability (MASA) | Change from Baseline in MASA at 8 weeks | The the Mann Assessment of Swallowing Ability (MASA) is designed to yield specific information about a patients's swallowing ability through examiner interpretation of responses. Two scores are obtained: a total score out of 200, and an ordinal risk rating for both aspiration and dysphagia (definite, probable, possible, unlikely). |
Countries
Taiwan
Outcome results
None listed