Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-01-09 @ 1:17 PM
Study NCT ID:
NCT00595933
Status:
COMPLETED
Last Update Posted:
2022-09-07
First Post:
2007-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Over-the-counter Dry Mouth Remedies After Radiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002638', 'term': 'Chewing Gum'}, {'id': 'D009067', 'term': 'Mouthwashes'}], 'ancestors': [{'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D002182', 'term': 'Candy'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D003358', 'term': 'Cosmetics'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2007-12-20', 'studyFirstSubmitQcDate': '2008-01-02', 'lastUpdatePostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effectiveness of seven over-the-counter remedies for dry mouth as determined by amount of saliva output and a brief questionaire.', 'timeFrame': '8-10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Head and Neck cancer', 'Radiation therapy', 'Dry mouth remedies', 'Dry Mouth', 'Xerostomia'], 'conditions': ['Xerostomia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effectiveness of over-the-counter remedies for dry mouth.', 'detailedDescription': 'Xerostomia (dry mouth) is the most common late complication of radiation therapy for head and neck cancers. When patients are cured or survive for several years, xerostomia often becomes quite bothersome; it affects their quality of life. This study compares the effectiveness of seven over-the-counter remedies, 2 rinses, 3 sprays and 2 chewing gums. A computer program will make random assignments so that the patient nor the physician will choose the order in which the products are tried. The remedies will be used for one week each and at the end of each period the patient will fill out a questionaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suffers from Xerostomia\n* Surviver of head and neck cancer that received \\>5000 cGy radiation therapy \\>1 year prior to study entry.\n* Able to chew, rinse and swallow.\n* Ages 13-99 years of age\n\nExclusion Criteria:\n\n* Currently using the following medications: anorexiants, antiacne agents, Anticholinergic agents, tricyclic antidepressants, chemotherapy agents.\n* Unable to complete questionnaires'}, 'identificationModule': {'nctId': 'NCT00595933', 'briefTitle': 'Comparing Over-the-counter Dry Mouth Remedies After Radiation', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'A Comparative Trial of Over-the-counter Dry Mouth Remedies for Dry Mouth After Radiation to the Head and Neck', 'orgStudyIdInfo': {'id': 'Dry Mouth_Krempl'}, 'secondaryIdInfos': [{'id': 'IRB # 12518', 'type': 'OTHER', 'domain': 'Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Each participant will receive an unidentified product to use for a one week period. This will continue until all 7 dry-mouth products have been evaluated.', 'interventionNames': ['Other: sugar-free chewing gum', 'Other: chewing gum', 'Other: mouth rinse', 'Drug: mouth spray']}], 'interventions': [{'name': 'sugar-free chewing gum', 'type': 'OTHER', 'otherNames': ['Freedent chewing gum'], 'description': 'Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.', 'armGroupLabels': ['1']}, {'name': 'chewing gum', 'type': 'OTHER', 'otherNames': ['Biotene chewing gum'], 'description': 'Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.', 'armGroupLabels': ['1']}, {'name': 'mouth rinse', 'type': 'OTHER', 'otherNames': ['Flavored water'], 'description': 'Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week questionaire', 'armGroupLabels': ['1']}, {'name': 'mouth rinse', 'type': 'OTHER', 'otherNames': ['Biotene mouth rinse'], 'description': 'Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.', 'armGroupLabels': ['1']}, {'name': 'mouth spray', 'type': 'DRUG', 'otherNames': ['Salivart'], 'description': 'Spray mouth with mouth spray 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week', 'armGroupLabels': ['1']}, {'name': 'mouth spray', 'type': 'DRUG', 'otherNames': ['MouthKote'], 'description': 'Spray mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Greg Krempl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}