Swallowing Exercises for Nasopharyngeal Cancer After Radiation Therapy
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|ClinicalTrials.gov Identifier: NCT01937793|
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : April 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Cancer Dysphagia||Other: effortful swallowing exercise Other: Mendelsohn swallowing exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Swallowing Exercises for Patients With Nasopharyngeal Cancer After Radiation Therapy|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Active Comparator: effortful swallowing exercise
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
voluntarily increases the posterior tongue base pushing effort while swallowing
Active Comparator: Mendelsohn swallowing exercise
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
voluntarily increase the extent and duration of laryngeal elevation while swallowing
- Change from Baseline in videofluoroscopic swallowing study (VFSS) [ Time Frame: 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.
- Change from Baseline in Chinese version of the Swallow Quality-of-Life Questionnaire (CSWAL-QOL) [ Time Frame: 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.
- Change from Baseline in the Mann Assessment of Swallowing Ability (MASA) [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937793
|National Taiwan University Hospital|
|Taipei city, Taiwan, 100|
|Principal Investigator:||Jenq-Yuh Ko, M.D., Ph.D.||National Taiwan University Hospital|