Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-05 @ 1:25 PM
Study NCT ID:
NCT05853692
Status:
RECRUITING
Last Update Posted:
2023-05-11
First Post:
2023-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Oral Mucositis in Head and Neck Cancer.
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The principal investigator will be encharged of generating the allocation sequence, of enrolling the participants and of assigning the interventions to the participants.\n\nThe coworkers who will evaluate the onset of OM and its severity will be blinded about the selected product.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will be conducted as a single-blind randomized clinical trial (RCT). The population will be divided into two groups, receiving respectively the medical device and a solution based on Sodium Bicarbonate (5 g/L)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2026-06-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2023-04-07', 'studyFirstSubmitQcDate': '2023-05-08', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral Mucositis', 'timeFrame': 'One week after the end of Radiotherapy', 'description': 'Yes/No'}], 'secondaryOutcomes': [{'measure': 'Time of Oral Mucositis Onset', 'timeFrame': 'From Day 0 to 2 months', 'description': 'Days'}, {'measure': 'Severity of Oral Mucositis', 'timeFrame': 'One week after the end of Radiotherapy', 'description': 'Difference in Oral Mucositis Grade'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Mucositis']}, 'descriptionModule': {'briefSummary': 'Oral Mucositis (OM) consists in the painful inflammation and ulceration of the mucous membranes lining the digestive tract, lasting between 7 and 98 days; and starts as an acute inflammation of oral mucosa, tongue, and pharynx after RT exposure.\n\nGel X spray is a product based on zinc gluconate. It could be helpful to achieve the prevention of Oral Mucositis and, in case of OM manifestation, the reduction of oral pain symptoms and to accelerate the healing process of oral mucositis ulcerations.\n\nThe aim of this study is to demonstrate the efficacy of the treatment with Gel X to reduce the incidence of oral mucositis, in comparison with Sodium Bicarbonate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosis of the following HNC: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy for curative purpose\n* Patients with diagnosis of HNC: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy as an adjuvant to surgical resection\n* Patients able self-apply the product.\n\nExclusion Criteria:\n\n* Patients with documented contraindication to any of the components of "Gel X" (there included eccipients): water, saccharin sodium, PVP, Taurine, Zinc Gluconate, PEG-40, Hydrogenated castor oil, Pullulan, Flavors\n* Patients with any neurological and psychiatric condition having an influence on the ability to self-apply the treatment\n* Patients participating to other clinical studies'}, 'identificationModule': {'nctId': 'NCT05853692', 'acronym': 'OMHNC-1', 'briefTitle': 'Prevention of Oral Mucositis in Head and Neck Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'officialTitle': 'Prevention of Oral Mucositis in Subjects Undergoing Radiotherapy for Head and Neck Cancer. A Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'ID 4576'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': 'The investigational product be administered for 63 days. Patient will use a spray based on zinc gluconate (three times a day)', 'interventionNames': ['Device: Zinc Gluconate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'The investigational product be administered for 63 days. Patient will use a solution based on sodium chloride and bicarbonate (5 times a day)', 'interventionNames': ['Device: Sodium Bicarbonate']}], 'interventions': [{'name': 'Zinc Gluconate', 'type': 'DEVICE', 'description': 'Three times a day (spray)', 'armGroupLabels': ['Test']}, {'name': 'Sodium Bicarbonate', 'type': 'DEVICE', 'description': 'Five times a day (rinse)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carlo Lajolo, Prof.', 'role': 'CONTACT', 'email': 'carlo.lajolo@unicatt.it', 'phone': '+393356078354'}], 'facility': 'Catholic University of the Sacred Hearth', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Carlo Lajolo, Prof.', 'role': 'CONTACT', 'email': 'carlo.lajolo@unicatt.it', 'phone': '+393401004585'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Carlo Lajolo', 'investigatorAffiliation': 'Catholic University of the Sacred Heart'}}}}