Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 10:59 PM
Study NCT ID:
NCT05214495
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2022-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omega-3 Hydrogel and Prevention of Oral Mucositis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013280', 'term': 'Stomatitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2022-01-02', 'studyFirstSubmitQcDate': '2022-01-27', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral Mucositis Severity', 'timeFrame': 'up to 6 weeks', 'description': 'Radiation induced head and neck toxicity will be scored by a scale based on clinical features from Common Terminology Criteria for Adverse Events (CTCAE) v5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mucositis Oral']}, 'descriptionModule': {'briefSummary': 'Oral mucositis (OM) is recognized as one of the most frequent debilitating sequela encountered by head and neck cancer (HNC) patients treated by radiotherapy. The objective of the study is to assess primarily the effect of topical oral Omega-3 hydrogel in prevention of radiation-induced oral mucositis and secondarily, to test the effect of topical oral Omega-3 hydrogel on oral microbiome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.\n2. Patients whose radiotherapy treatment planned dose is 50 Gy or above\n3. Males and females with an age not less than 18 years\n4. Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.\n\nExclusion Criteria:\n\n1. Patients under Anticoagulants such as warfarin, heparin, or aspirin.\n2. Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)\n3. Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.'}, 'identificationModule': {'nctId': 'NCT05214495', 'briefTitle': 'Omega-3 Hydrogel and Prevention of Oral Mucositis', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Efficacy of Topical Oral Omega-3 Hydrogel in Prevention of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '0290-09/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical oral Omega-3 hydrogel group', 'description': 'Patients will be given topical oral Omega-3 hydrogel', 'interventionNames': ['Drug: topical oral Omega-3 hydrogel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional preventive treatment group', 'description': 'Patients will be given conventional preventive treatment', 'interventionNames': ['Drug: conventional preventive treatment']}], 'interventions': [{'name': 'topical oral Omega-3 hydrogel', 'type': 'DRUG', 'description': 'Topical oral Omega-3 hydrogel prepared from fish oil', 'armGroupLabels': ['Topical oral Omega-3 hydrogel group']}, {'name': 'conventional preventive treatment', 'type': 'DRUG', 'description': 'topical treatment including antifungal agents, anti-inflammatory mouthwash, sodium bicarbonate mouthwash.\n\nTopical anesthetics agent, topical analgesic gel as well as systemic analgesics (if needed)', 'armGroupLabels': ['Conventional preventive treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Basma Morsy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Basma Morsy', 'investigatorAffiliation': 'Alexandria University'}}}}