Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-30 @ 7:28 PM
Study NCT ID:
NCT01195233
Status:
COMPLETED
Last Update Posted:
2011-04-19
First Post:
2010-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Analysis of BioXtra on Xerostomia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014987', 'term': 'Xerostomia'}], 'ancestors': [{'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C460819', 'term': 'BioXtra'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-18', 'studyFirstSubmitDate': '2010-08-27', 'studyFirstSubmitQcDate': '2010-09-03', 'lastUpdatePostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement of xerostomia', 'timeFrame': '2 weeks', 'description': 'change of symptoms of xerostomia is measured by Visual Analogue Scale and Dichotomos questionnaire\\[ Time Frame: baseline compared with measures on day 14'}], 'secondaryOutcomes': [{'measure': 'comparative analysis of improvement xerostomia between 2 drugs', 'timeFrame': '5 weeks', 'description': 'change of symptoms of xerostomia is measured by Visual Analogue Scale and Dichotomos questionnaire\\[ Time Frame: baseline compared with measures on day 35 and comparative analysis between BioXtra spray and mouth rinse'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Xerostomia', 'Radiotherapy of head and neck', 'BioXtra'], 'conditions': ['Radiation-Induced Xerostomia']}, 'descriptionModule': {'briefSummary': 'The present study compared the efficacy of BioXtra spray and mouth rinse in the relief of radiotherapy-induced xerostomia in patients referred to Cancer Institute, Tehran Imam Khomeini Hospital.', 'detailedDescription': 'Xerostomia or dry mouth is an important complication of radiotherapy for head and neck regions producing serious discomfort for patients with a significant reduction in their quality of life. Symptomatic treatments for the disease include maintain oral hygiene and use of artificial saliva substitutes.\n\nDue to limited studies on efficacy compounds BioXtra, present study compared the effects of spray and mouth rinse BioXtra in symptoms of xerostomia in patients under head and neck cancer radiotherapy .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* complaint of xerostomia after head and neck radiotherapy\n* patient must have given written informed consent\n\nExclusion Criteria:\n\n* age under 18 years\n* history of any treatment for cancer in the last 3 months\n* recurrence of cancer and end stage of it\n* diabetes mellitus\n* sjogren syndrome or other medical causes of xerostomia\n* drug therapy which might induce xerostomia\n* refusal of cooperation or consent'}, 'identificationModule': {'nctId': 'NCT01195233', 'acronym': 'BioXtra', 'briefTitle': 'Comparative Analysis of BioXtra on Xerostomia', 'organization': {'class': 'OTHER', 'fullName': 'Qazvin University Of Medical Sciences'}, 'officialTitle': 'Comparison Study of BioXtra Spray and Mouth Rinse in Patient With Radiation-induced Xerostomia', 'orgStudyIdInfo': {'id': 'QUMS 1350'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'bioxtra spray and mouth rinse', 'description': 'Drug: BioXtra spray or mouth rinse Patients had been xerostomia due to radiation of head and neck were selected for the study. Gender, age, medical history, VAS, dichotomous questionnaire of xerostomia , and other treatment used for this disease were recorded. Local ethical committee approval was obtained before the trial started and all patients gave written informed consent. Patients were randomly divided into two groups .First group received BioXtra spray and second group used BioXtra mouth rinse for 2 weeks and then 1 weeks wash -out period and for other 2 weeks drugs is switched . Each patients was examined at the beginning of the therapy ,and then 2 weeks after therapy and 35 days after first visit.', 'interventionNames': ['Drug: bioxtra']}], 'interventions': [{'name': 'bioxtra', 'type': 'DRUG', 'otherNames': ['saliva subsitute'], 'description': 'spray /mouth rinse', 'armGroupLabels': ['bioxtra spray and mouth rinse']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3415759811', 'city': 'Qazvin', 'state': 'Qazvin Province', 'country': 'Iran', 'facility': 'Qazvin University of Medical Sciences', 'geoPoint': {'lat': 36.26877, 'lon': 50.0041}}], 'overallOfficials': [{'name': 'Mahin Bakhshi, DDS/MS', 'role': 'STUDY_CHAIR', 'affiliation': 'Qazvin University Of Medical Sciences'}, {'name': 'Touba Karagah, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'QUMS'}, {'name': 'Soheila Manifar, DDS/MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Imam Khomeini Hospital'}, {'name': 'Navid Mohamadi, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'QUMS'}, {'name': 'Abbas Hosseinmardi, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'QUMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qazvin University Of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imam Khomeini Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr Mahin Bakhshi', 'oldOrganization': 'Qazvin University Of Medical Sciences'}}}}