Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 4:22 AM
Study NCT ID:
NCT07467759
Status:
COMPLETED
Last Update Posted:
2026-03-17
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benzydamine for Radiation-Induced Oral Mucositis in Patients Receiving High-Dose Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001591', 'term': 'Benzydamine'}], 'ancestors': [{'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomized in a 1:1 ratio to one of two parallel groups: benzydamine oral spray plus standard oral care or standard oral care alone'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-08', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weekly severity of oral mucositis', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Oral mucositis severity was assessed weekly for 6 weeks by a specialist using the World Health Organization (WHO) oral mucositis grading scale. The scale ranges from 0 to 4, where 0 indicates no mucositis and 4 indicates sever mucositis. Higher represent worse severity.'}], 'secondaryOutcomes': [{'measure': 'Between-group difference in oral mucositis severity at weeks 4 and 6', 'timeFrame': 'Week 4 and week 6', 'description': 'Between-group differences in oral mucositis severity were assessed at week 4 and week 6 using the World Health Organization (WHO) oral mucositis grading scale. The scale ranges from 0 to 4, where 0 indicates no mucositis and 4 indicates sever mucositis. Higher represent worse severity.'}, {'measure': 'Proportion of patients who developed grade 3 oral mucositis', 'timeFrame': 'During the 6-week follow-up period', 'description': 'The proportion of patients who developed grade 3 oral mucositis during the 6-week follow-up period was assessed using the World Health Organization (WHO) oral mucositis grading scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Benzydamine', 'Radiation-induced oral mucositis', 'Head and neck cnacer', 'Supportive care'], 'conditions': ['Radiation-induced Oral Mucositis']}, 'descriptionModule': {'briefSummary': 'This single-center, open-label, randomized clinical trial evaluates the effect of 0.15% benzydamine hydrochloride (Difflam) oral spray on the severity of radiation-induced oral mucositis in patients with head and neck cancer receiving high-dose radiotherapy (≥50 Gy) without concurrent chemotherapy. Oral mucositis is a common and clinically significant complication of radiotherapy that can cause pain, difficulty swallowing, nutritional impairment, and treatment interruption.\n\nParticipants are randomly assigned to receive either standard oral care alone or standard oral care plus benzydamine oral spray for 6 weeks. Oral mucositis severity is assessed weekly using the World Health Organization (WHO) oral mucositis grading scale. The study aims to determine whether benzydamine reduces the progression and severity of oral mucositis in this patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 22 years or older\n* Pathologically confirmed head and neck cancer\n* Currently undergoing RT\n* Cumulative total radiation dose exceeding 50 Gy\n* Patients were enrolled in the study after their diagnosis of OM was confirmed by a specialist, which occurred approximately two weeks after the initiation of radiotherapy\n* All subjects had grade 1 OM according to the WHO criteria at baseline, except for two patients in the intervention group who presented with grade 2 severity at the start of the study\n* None of participants received concurrent chemotherapy during the study period\n\nExclusion Criteria:\n\n* Use of concurrent treatments affecting OM\n* Incomplete follow-up\n* Other conditions influencing its progression\n* patient withdrawal'}, 'identificationModule': {'nctId': 'NCT07467759', 'briefTitle': 'Benzydamine for Radiation-Induced Oral Mucositis in Patients Receiving High-Dose Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Tishreen University'}, 'officialTitle': 'The Effect of 0.15% Benzydamine Hydrochloride (Difflam) Oral Spray on the Severity of Radiation-induced Oral Mucositis in Patients Receiving High-Dose Radiotherapy: An Open-Label Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'LATAKIA-ONC-BENZ-2025-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Benzydamine plus standard oral care', 'description': 'participants in this arm received standard oral care, including routine oral hygiene measures and saline mouth rinses, in addition to 0.15% benzydamine hydrochloride oral spray for 6 weeks.', 'interventionNames': ['Drug: benzydamine hydrochloride', 'Other: saline mouth rinse']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard oral care alone', 'description': 'participants in this arm received standard oral care alone, including routine oral hygiene measures and saline mouth rinses, without benzydamine oral spray.', 'interventionNames': ['Other: saline mouth rinse']}], 'interventions': [{'name': 'benzydamine hydrochloride', 'type': 'DRUG', 'description': 'Benzydamine hydrochloride 0.15% oral spray administered as 4 to 8 sprays, 4 to 6 times daily, for 6 weeks, in addition to standard oral care', 'armGroupLabels': ['Benzydamine plus standard oral care']}, {'name': 'saline mouth rinse', 'type': 'OTHER', 'description': 'standard oral care consisted of routine oral hygiene measures and saline mouth rinses.', 'armGroupLabels': ['Benzydamine plus standard oral care', 'Standard oral care alone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Latakia', 'country': 'Syria', 'facility': 'Pharmacy, Latakia university', 'geoPoint': {'lat': 35.53125, 'lon': 35.79088}}], 'overallOfficials': [{'name': 'Rama Ibrahim, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Latakia university, Latakia, Syria'}, {'name': 'Bassam Saad, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Latakia university, Latakia, Syria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tishreen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}