Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-31 @ 5:20 PM
Study NCT ID:
NCT01937793
Status:
COMPLETED
Last Update Posted:
2014-04-17
First Post:
2013-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swallowing Exercises for Nasopharyngeal Cancer After Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-16', 'studyFirstSubmitDate': '2013-01-30', 'studyFirstSubmitQcDate': '2013-09-04', 'lastUpdatePostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from Baseline in the Mann Assessment of Swallowing Ability (MASA)', 'timeFrame': 'Change from Baseline in MASA at 8 weeks', 'description': "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)."}], 'primaryOutcomes': [{'measure': 'Change from Baseline in videofluoroscopic swallowing study (VFSS)', 'timeFrame': 'Change from Baseline in VFSS at 8 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Chinese version of the Swallow Quality-of-Life Questionnaire (CSWAL-QOL)', 'timeFrame': 'Change from Baseline in CSWAL-QOL at 8 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['radiation', 'speech-language pathology'], 'conditions': ['Nasopharyngeal Cancer', 'Dysphagia']}, 'referencesModule': {'references': [{'pmid': '11733879', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11898144', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10862024', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22508621', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17202944', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16735913', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20204414', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12169803', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9121786', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11984518', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21136031', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20623305', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20510985', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10737318', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.asha.org/', 'label': 'American Speech-Language-Hearing Association'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed with NPC\n* completed radiation therapy at least 1 year\n* mild to moderate swallowing disorder defined by videofluorography\n* able to comply with protocal mandate, willing to perform the exercise programs, and ability to attend the weekly sessions\n\nExclusion Criteria:\n\n* feeding tube insitu\n* received pharyngeal surgery\n* tracheostomy tube insitu\n* patients who could not put effort to push posterior tongue base backward and who could not elevate their pharyngeal during swallowing\n* severe swallowing disorder or aspirate defined by videofluorography\n* other malignances, neurovascular disease, demyelinating disease\n* cancer relapse or metastases'}, 'identificationModule': {'nctId': 'NCT01937793', 'briefTitle': 'Swallowing Exercises for Nasopharyngeal Cancer After Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Swallowing Exercises for Patients With Nasopharyngeal Cancer After Radiation Therapy', 'orgStudyIdInfo': {'id': '201211062RIB'}, 'secondaryIdInfos': [{'id': '000766KJY', 'type': 'OTHER', 'domain': 'National Taiwan University Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'effortful swallowing exercise', 'description': '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.', 'interventionNames': ['Other: effortful swallowing exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mendelsohn swallowing exercise', 'description': '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.', 'interventionNames': ['Other: Mendelsohn swallowing exercise']}], 'interventions': [{'name': 'effortful swallowing exercise', 'type': 'OTHER', 'description': 'voluntarily increases the posterior tongue base pushing effort while swallowing', 'armGroupLabels': ['effortful swallowing exercise']}, {'name': 'Mendelsohn swallowing exercise', 'type': 'OTHER', 'description': 'voluntarily increase the extent and duration of laryngeal elevation while swallowing', 'armGroupLabels': ['Mendelsohn swallowing exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Jenq-Yuh Ko, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}