Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-28 @ 8:43 PM
Study NCT ID:
NCT04308161
Status:
UNKNOWN
Last Update Posted:
2020-03-13
First Post:
2020-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-12', 'studyFirstSubmitDate': '2020-03-12', 'studyFirstSubmitQcDate': '2020-03-12', 'lastUpdatePostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in severity of oral mucositis at different time points along the study', 'timeFrame': 'up to 3 and 6 weeks', 'description': 'Oral mucositis will be evaluated by the World Health Organization (WHO) scale which record the extent and severity of oral mucositis at the third and sixth week after the first radiotherapy session.'}], 'secondaryOutcomes': [{'measure': 'Pain and discomfort severity at different time points along the study: Numeric Rating Scale', 'timeFrame': 'up to 3 and 6 weeks', 'description': 'Discomfort and pain severity were reported by each patient using Numeric Rating Scale (NRS) at the third and sixth week after the first radiotherapy session.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitamin D topical oral gel'], 'conditions': ['Oral Mucositis Due to Radiation']}, 'referencesModule': {'references': [{'pmid': '16033826', 'type': 'BACKGROUND', 'citation': 'Muanza TM, Cotrim AP, McAuliffe M, Sowers AL, Baum BJ, Cook JA, Feldchtein F, Amazeen P, Coleman CN, Mitchell JB. Evaluation of radiation-induced oral mucositis by optical coherence tomography. Clin Cancer Res. 2005 Jul 15;11(14):5121-7. doi: 10.1158/1078-0432.CCR-05-0403.'}, {'pmid': '28589080', 'type': 'BACKGROUND', 'citation': 'Maria OM, Eliopoulos N, Muanza T. Radiation-Induced Oral Mucositis. Front Oncol. 2017 May 22;7:89. doi: 10.3389/fonc.2017.00089. eCollection 2017.'}, {'type': 'BACKGROUND', 'citation': 'Rogulj AA, Brzak BL, Boras VV, Brailo V, Milenović M. Oral complications of head and neck irradiation. Libr Oncol. 2017;45(2-3):89-93.'}, {'pmid': '25345344', 'type': 'BACKGROUND', 'citation': 'Barkokebas A, Silva IH, de Andrade SC, Carvalho AA, Gueiros LA, Paiva SM, Leao JC. Impact of oral mucositis on oral-health-related quality of life of patients diagnosed with cancer. J Oral Pathol Med. 2015 Oct;44(9):746-51. doi: 10.1111/jop.12282. 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No abstract available.'}, {'pmid': '26512725', 'type': 'BACKGROUND', 'citation': 'Musha A, Shimada H, Shirai K, Saitoh J, Yokoo S, Chikamatsu K, Ohno T, Nakano T. Prediction of Acute Radiation Mucositis using an Oral Mucosal Dose Surface Model in Carbon Ion Radiotherapy for Head and Neck Tumors. PLoS One. 2015 Oct 29;10(10):e0141734. doi: 10.1371/journal.pone.0141734. eCollection 2015.'}, {'pmid': '16775649', 'type': 'BACKGROUND', 'citation': 'McGuire DB, Correa ME, Johnson J, Wienandts P. The role of basic oral care and good clinical practice principles in the management of oral mucositis. Support Care Cancer. 2006 Jun;14(6):541-7. doi: 10.1007/s00520-006-0051-8. Epub 2006 Apr 25.'}, {'pmid': '21092237', 'type': 'BACKGROUND', 'citation': 'Vashi PG, Trukova K, Lammersfeld CA, Braun DP, Gupta D. Impact of oral vitamin D supplementation on serum 25-hydroxyvitamin D levels in oncology. Nutr J. 2010 Nov 23;9:60. doi: 10.1186/1475-2891-9-60.'}, {'pmid': '1026900', 'type': 'BACKGROUND', 'citation': 'Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available.'}, {'pmid': '3078045', 'type': 'BACKGROUND', 'citation': 'McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007-19. doi: 10.1017/s0033291700009934.'}]}, 'descriptionModule': {'briefSummary': 'The main aim of this study was to evaluate clinically the effect of topical oral vitamin D gel in comparison to conventional therapy in prevention of radiation - induced oral mucositis', 'detailedDescription': 'The study was designed as randomized, controlled, clinical trial. patients who were undergoing to receive radiotherapy were divided into three groups: Group I: was given conventional treatment.Group II : was given topical oral gel of vitamin D. Group III: was given topical oral gel of vitamin D in combination with the conventional treatment.\n\nAll patients were clinically evaluated at the start the radiotherapy, three weeks and six weeks later for pain and oral mucositis severity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.\n* Patients whose radiotherapy treatment planned dose is 50 Gy or above.\n* Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.\n\nExclusion Criteria:\n\n* Patients under Anticoagulants such as warfarin, heparin, or aspirin.\n* Patients whose radiotherapy treatment planned dose is lower than 50 Gy.\n* Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)\n* Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.\n* Hyper-calcemic patients.\n* Smokers.'}, 'identificationModule': {'nctId': 'NCT04308161', 'briefTitle': 'Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'The Effectiveness of Topical Oral Vitamin D Gel in Prevention of Radiation-induced Oral Mucositis', 'orgStudyIdInfo': {'id': 'IRB NO: 00010556-IORG 0008839'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vitamin D oral gel', 'description': 'Topical oral vitamin D gel twice daily (Equivalent to 8000 I.U/day vitamin D) for six weeks.\n\nTopical oral Vitamin D gel is prepared with the aid of pharmaceutics department, faculty of pharmacy, Alexandria University. It is prepared by using Cholecalciferol 2ml ampoule (200.000 I.U.) within topical oral gel formulation.', 'interventionNames': ['Drug: vitamin D oral gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional therapy', 'description': 'Conventional therapy (symptomatic treatment) which included:\n\n* Miconaz oral gel\n* BBC oral spray\n* Oracure gel\n* Alkamisr sachets\n\nDose: Three times a day for six weeks', 'interventionNames': ['Drug: Miconazole Topical Gel', 'Drug: BBC oral spray', 'Drug: Oracure gel', 'Other: Alkamisr sachets']}, {'type': 'EXPERIMENTAL', 'label': 'combination therapy', 'description': 'Topical oral vitamin D gel twice daily (Equivalent to 8000 I.U/day vitamin D) for six weeks in combination with the symptomatic treatment\n\nSymptomatic treatment which included:\n\n* Miconaz oral gel\n* BBC oral spray\n* Oracure gel\n* Alkamisr sachets\n\nSymptomatic treatment dose: Three times a day for six weeks', 'interventionNames': ['Drug: vitamin D oral gel', 'Drug: Miconazole Topical Gel', 'Drug: BBC oral spray', 'Drug: Oracure gel', 'Other: Alkamisr sachets']}], 'interventions': [{'name': 'vitamin D oral gel', 'type': 'DRUG', 'description': 'vitamin D is a fat soluble vitamin which has important calcemic roles in the body regarding bone homeostasis and calcium/phosphorus balance. Recently, the non-calcemic roles of vitamin D as anti-inflammatory, anti-oxidant and immuno-regulatory functions have been widely reported.So, we tried to use it for prevention of radiation induced oral mucositis', 'armGroupLabels': ['combination therapy', 'vitamin D oral gel']}, {'name': 'Miconazole Topical Gel', 'type': 'DRUG', 'description': 'topical anti fungal agent', 'armGroupLabels': ['combination therapy', 'conventional therapy']}, {'name': 'BBC oral spray', 'type': 'DRUG', 'description': 'Topical anesthetics and anti-inflammatory agent', 'armGroupLabels': ['combination therapy', 'conventional therapy']}, {'name': 'Oracure gel', 'type': 'DRUG', 'description': 'Topical analgesic gel', 'armGroupLabels': ['combination therapy', 'conventional therapy']}, {'name': 'Alkamisr sachets', 'type': 'OTHER', 'description': 'Sodium bicarbonate mouthwash', 'armGroupLabels': ['combination therapy', 'conventional therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Islam s Bakr, BDS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Islam s Bakr, BDS', 'role': 'CONTACT', 'email': 'dent.bakr@gmail.com', 'phone': '1067809063', 'phoneExt': '0020'}], 'overallOfficials': [{'name': 'Islam s Bakr, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}, {'name': 'azza m zaki, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}, {'name': 'Riham m El-Moslemany, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}, {'name': 'Rasha o Elsaka, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}