- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01937793
Swallowing Exercises for Nasopharyngeal Cancer After Radiation Therapy
April 16, 2014 updated by: National Taiwan University Hospital
Swallowing Exercises for Patients With Nasopharyngeal Cancer After Radiation Therapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei city, Taiwan, 100
- National Taiwan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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voluntarily increases the posterior tongue base pushing effort while swallowing
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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.
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voluntarily increase the extent and duration of laryngeal elevation while swallowing
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in videofluoroscopic swallowing study (VFSS)
Time Frame: Change from Baseline in VFSS at 8 weeks
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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.
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Change from Baseline in VFSS at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Change from Baseline in CSWAL-QOL at 8 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in the Mann Assessment of Swallowing Ability (MASA)
Time Frame: Change from Baseline in MASA at 8 weeks
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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).
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Change from Baseline in MASA at 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jenq-Yuh Ko, M.D., Ph.D., National Taiwan University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lazarus C, Logemann JA, Song CW, Rademaker AW, Kahrilas PJ. Effects of voluntary maneuvers on tongue base function for swallowing. Folia Phoniatr Logop. 2002 Jul-Aug;54(4):171-6. doi: 10.1159/000063192.
- Kulbersh BD, Rosenthal EL, McGrew BM, Duncan RD, McColloch NL, Carroll WR, Magnuson JS. Pretreatment, preoperative swallowing exercises may improve dysphagia quality of life. Laryngoscope. 2006 Jun;116(6):883-6. doi: 10.1097/01.mlg.0000217278.96901.fc.
- Hind JA, Nicosia MA, Roecker EB, Carnes ML, Robbins J. Comparison of effortful and noneffortful swallows in healthy middle-aged and older adults. Arch Phys Med Rehabil. 2001 Dec;82(12):1661-5. doi: 10.1053/apmr.2001.28006.
- Huang HY, Wilkie DJ, Schubert MM, Ting LL. Symptom profile of nasopharyngeal cancer patients during radiation therapy. Cancer Pract. 2000 Nov-Dec;8(6):274-81. doi: 10.1046/j.1523-5394.2000.86007.x.
- Hughes PJ, Scott PM, Kew J, Cheung DM, Leung SF, Ahuja AT, van Hasselt CA. Dysphagia in treated nasopharyngeal cancer. Head Neck. 2000 Jul;22(4):393-7. doi: 10.1002/1097-0347(200007)22:43.0.co;2-2.
- Kotz T, Federman AD, Kao J, Milman L, Packer S, Lopez-Prieto C, Forsythe K, Genden EM. Prophylactic swallowing exercises in patients with head and neck cancer undergoing chemoradiation: a randomized trial. Arch Otolaryngol Head Neck Surg. 2012 Apr;138(4):376-82. doi: 10.1001/archoto.2012.187.
- Ku PK, Yuen EH, Cheung DM, Chan BY, Ahuja A, Leung SF, Tong MC, van Hasselt A. Early swallowing problems in a cohort of patients with nasopharyngeal carcinoma: Symptomatology and videofluoroscopic findings. Laryngoscope. 2007 Jan;117(1):142-6. doi: 10.1097/01.mlg.0000248738.55387.44.
- Lam PM, Lai CK. The validation of the Chinese version of the Swallow Quality-of-Life Questionnaire (SWAL-QOL) using exploratory and confirmatory factor analysis. Dysphagia. 2011 Jun;26(2):117-24. doi: 10.1007/s00455-010-9272-6. Epub 2010 Mar 4.
- Logemann JA. Role of the modified barium swallow in management of patients with dysphagia. Otolaryngol Head Neck Surg. 1997 Mar;116(3):335-8. doi: 10.1016/S0194-59989770269-9.
- Shaker R, Easterling C, Kern M, Nitschke T, Massey B, Daniels S, Grande B, Kazandjian M, Dikeman K. Rehabilitation of swallowing by exercise in tube-fed patients with pharyngeal dysphagia secondary to abnormal UES opening. Gastroenterology. 2002 May;122(5):1314-21. doi: 10.1053/gast.2002.32999.
- Tang Y, Shen Q, Wang Y, Lu K, Wang Y, Peng Y. A randomized prospective study of rehabilitation therapy in the treatment of radiation-induced dysphagia and trismus. Strahlenther Onkol. 2011 Jan;187(1):39-44. doi: 10.1007/s00066-010-2151-0. Epub 2010 Dec 10.
- van der Molen L, van Rossum MA, Burkhead LM, Smeele LE, Rasch CR, Hilgers FJ. A randomized preventive rehabilitation trial in advanced head and neck cancer patients treated with chemoradiotherapy: feasibility, compliance, and short-term effects. Dysphagia. 2011 Jun;26(2):155-70. doi: 10.1007/s00455-010-9288-y. Epub 2010 Jul 11.
- Wang TG, Chang YC, Chen WS, Lin PH, Hsiao TY. Reduction in hyoid bone forward movement in irradiated nasopharyngeal carcinoma patients with dysphagia. Arch Phys Med Rehabil. 2010 Jun;91(6):926-31. doi: 10.1016/j.apmr.2010.02.011.
- Wu CH, Hsiao TY, Ko JY, Hsu MM. Dysphagia after radiotherapy: endoscopic examination of swallowing in patients with nasopharyngeal carcinoma. Ann Otol Rhinol Laryngol. 2000 Mar;109(3):320-5. doi: 10.1177/000348940010900315.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
January 30, 2013
First Submitted That Met QC Criteria
September 4, 2013
First Posted (Estimate)
September 10, 2013
Study Record Updates
Last Update Posted (Estimate)
April 17, 2014
Last Update Submitted That Met QC Criteria
April 16, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Carcinoma
- Nasopharyngeal Neoplasms
Other Study ID Numbers
- 201211062RIB
- 000766KJY (Other Identifier: National Taiwan University Hospital)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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