Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-31 @ 3:19 PM
Study NCT ID:
NCT01833650
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2013-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012793', 'term': 'Sialadenitis'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-24', 'studyFirstSubmitDate': '2013-04-11', 'studyFirstSubmitQcDate': '2013-04-13', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Salivary Quantity (Quantitative Salivary Scintigraphy)', 'timeFrame': 'Change from Baseline quantity of saliva at 6 and 24 months'}], 'primaryOutcomes': [{'measure': 'Grade of sialadenitis', 'timeFrame': 'Change from Baseline grade of sialadenitis at 6 and 24 months'}], 'secondaryOutcomes': [{'measure': 'Grade of Xerostomia', 'timeFrame': 'Change from Baseline grade of xerostomia at 6 and 24 months'}, {'measure': 'Level of Health related quality of life', 'timeFrame': 'Change from Baseline level of health related quality of life at 6 and 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['thyroid cancer', 'radioiodine treatment', 'xerostomia', 'sialadenitis'], 'conditions': ['Thyroid Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the use of honey mouthwashes in the prevention of salivary side effects of 131I (radioiodine) therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years old\n* They had a histological diagnosis of papillary, follicular, medullary or anaplastic thyroid cancer\n* They had undergone total thyroidectomy\n* They were able to provide consent\n\nExclusion Criteria:\n\n* patients who had distant metastases,\n* a history of salivary-gland disorders,\n* collagen tissue disease\n* diabetes mellitus,\n* previous radioiodine therapy or external radiation to the head or neck\n* allergy to the honey'}, 'identificationModule': {'nctId': 'NCT01833650', 'briefTitle': 'The Use of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cyprus University of Technology'}, 'officialTitle': 'A Randomized Controlled Trial of the Effectiveness of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer', 'orgStudyIdInfo': {'id': 'AC-HCS-89'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'This arm represents the current standard care in patients with thyroid cancer undergoing radioiodine.'}, {'type': 'EXPERIMENTAL', 'label': 'Candy plus thymus honey mouthwash 12', 'description': 'This arm will consist 30 patients and will be the one of the intervention groups where each patient will be instructed to suck 1 or 2 lemon candies every 2-3 h in the daytime plus 4 thymus honey mouthwashes in between (at least one hour after the candy sucking) starting 12 hours after the ingestion of 131I therapy and for a duration of no more than 4 days.', 'interventionNames': ['Dietary Supplement: thymus honey mouthwash']}, {'type': 'EXPERIMENTAL', 'label': 'Candy plus thymus honey mouthwash 24', 'description': 'This arm will consist 30 patients and will be the one of the intervention groups where each patient will be instructed to suck 1 or 2 lemon candies every 2-3 h in the daytime plus 4 thymus honey mouthwashes in between (at least one hour after the candy sucking) starting 24 hours after the ingestion of 131I therapy and for a duration of no more than 4 days.', 'interventionNames': ['Dietary Supplement: thymus honey mouthwash']}, {'type': 'EXPERIMENTAL', 'label': 'Candy plus thymus honey mouthwash 1', 'description': 'This arm will consist 30 patients and will be the one of the intervention groups where each patient will be instructed to suck 1 or 2 lemon candies every 2-3 h in the daytime plus 4 thymus honey mouthwashes in between (at least one hour after the candy sucking) starting immediate after the ingestion of 131I therapy (about 1 hour) and for a duration of no more than 4 days', 'interventionNames': ['Dietary Supplement: thymus honey mouthwash']}], 'interventions': [{'name': 'thymus honey mouthwash', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Candy plus thymus honey mouthwash 1', 'Candy plus thymus honey mouthwash 12', 'Candy plus thymus honey mouthwash 24']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2006', 'city': 'Nicosia', 'country': 'Cyprus', 'facility': 'Bank of Cyprus Oncology', 'geoPoint': {'lat': 35.17284, 'lon': 33.35397}}], 'overallOfficials': [{'name': 'Andreas Charalambous, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cyprus University of Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cyprus University of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bank of Cyprus Oncology Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Oncology and Palliative Care', 'investigatorFullName': 'Dr. Andreas Charalambous', 'investigatorAffiliation': 'Cyprus University of Technology'}}}}