Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-03-02 @ 4:12 AM
Study NCT ID:
NCT02156518
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2014-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Vocal Function Exercises for Laryngeal Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007822', 'term': 'Laryngeal Neoplasms'}], 'ancestors': [{'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2014-06-03', 'studyFirstSubmitQcDate': '2014-06-04', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Voice production', 'timeFrame': '6 weeks', 'description': 'Voice Handicap Index, a validated self- assessment tool was used as the primary outcome measure. A score of 0 indicates no handicap, and a score of 120 indicates complete impairment. Data will be presented as pre and post treatment score (pre and post 6 weeks of therapy).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radiation therapy, laryngeal cancer, voice therapy, vocal function exercises'], 'conditions': ['Vocal Folds']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the systematic practice of Vocal Function Exercises (VFE) improves selected measures of voice production in participants who have previously been irradiated for early glottic cancers compared to participants who receive the present standard of care, namely, vocal hygiene counseling. It is hypothesized that a prescriptive vocal exercise program (VFE) will improve the voice production of individuals who have been previously treated for laryngeal cancers when compared to participants who receive vocal hygiene alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hearing level and cognitive ability to follow test directions\n* Laryngeal cancer\n* Radiation Therapy completed \\>= 6 months\n* Deemed disease free by the treating physician\n* Subjects have to be willing to attend weekly voice therapy sessions\n\nExclusion Criteria:\n\n* Adjuvant treatment: laser or any surgical intervention\n* Neurological or cognitive impairment\n* Hearing levels that interfere with following test instruction\n* Vocal fold paralysis'}, 'identificationModule': {'nctId': 'NCT02156518', 'briefTitle': 'The Efficacy of Vocal Function Exercises for Laryngeal Cancers', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Investigating the Efficacy of Vocal Function Exercises in the Treatment of Voice Problems in Adults Treated With Radiation Therapy for Laryngeal Cancers', 'orgStudyIdInfo': {'id': '2014-027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vocal Function Exercises', 'description': 'Vocal Function Exercises', 'interventionNames': ['Procedure: Vocal Function Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vocal hygiene', 'description': 'Vocal hygiene', 'interventionNames': ['Procedure: Vocal Hygiene']}], 'interventions': [{'name': 'Vocal Function Exercises', 'type': 'PROCEDURE', 'description': 'Vocal Function Exercises', 'armGroupLabels': ['Vocal Function Exercises']}, {'name': 'Vocal Hygiene', 'type': 'PROCEDURE', 'description': 'Vocal Hygiene', 'armGroupLabels': ['Vocal hygiene']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky, Markey Cancer Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Vrushali Angadi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky, Department of Rehabilitation Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vrushali Angadi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vrushali Angadi', 'investigatorAffiliation': 'University of Kentucky'}}}}