NCT01937793|Completed
Swallowing Exercises for Nasopharyngeal Cancer After Radiation Therapy
Swallowing Exercises for Patients With Nasopharyngeal Cancer After Radiation Therapy
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Swallowing Exercises for Patients With Nasopharyngeal Cancer After Radiation Therapy
Sponsor study identifier
Secondary identifiers
OTHER · National Taiwan University Hospital
interventional
16
1 country
1
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 30, 2013
Actual (reported)September 10, 2013
Actual (reported)December 2013
Actual (reported)December 2013
Actual (reported)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
Change from Baseline in Chinese version of the Swallow Quality-of-Life Questionnaire (CSWAL-QOL)
Change from Baseline in CSWAL-QOL at 8 weeks
Change from Baseline in the Mann Assessment of Swallowing Ability (MASA)
Change from Baseline in MASA at 8 weeks
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.
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.
voluntarily increases the posterior tongue base pushing effort while swallowing
voluntarily increase the extent and duration of laryngeal elevation while swallowing
National Taiwan University Hospital
Taipei, Taiwan, 100, Taiwan
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.
Jenq-Yuh Ko, M.D., Ph.D.
National Taiwan University Hospital
16 participants (actual enrollment reported by the registry).
First Submitted
January 30, 2013
First Posted
September 10, 2013
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Comprehensive Oral Care Long-term Care Facilities
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
April 17, 2014
Record last verified: 2014-04
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