Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-01-16 @ 5:53 PM
Study NCT ID:
NCT01400620
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2011-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-12', 'studyFirstSubmitDate': '2011-07-20', 'studyFirstSubmitQcDate': '2011-07-21', 'lastUpdatePostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of WHO score 3-4 Oral Mucositis at a Cumulative Radiation Dosage of 50 Gy in the active and Placebo Groups', 'timeFrame': 'Participants will be assessed twice per week during the duration of chemoradiation therapy anticipated to be 5-7 weeks. Following chemoradiation therapy the participants will be assessed weekly for two weeks.', 'description': 'Degree of oral mucositis will be scored using WHO scoring system bi-weekly throughout course of the trial'}], 'secondaryOutcomes': [{'measure': 'Incidence of grade 2-3-4 Oral Mucositis as measured by the WHO scale at increasing increments of cumulative radiation exposure', 'timeFrame': 'Participants will be assessed twice per week during the duration of chemoradiation therapy anticipated to be 5-7 weeks. Following chemoradiation therapy the participants will be assessed weekly for two weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['oral mucositis', 'chemoradiation', 'head and neck cancer'], 'conditions': ['Oral Mucositis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy for head and neck cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of head and neck cancer\n* planned treatment course to include Cisplatin and radiation therapy, cumulative prescription dose between 50-70 Gy\n* able to eat at least soft solids\n* normal cardiac function\n* able to perform oral rinse\n\nExclusion Criteria:\n\n* Induction chemotherapy regimen\n* life threatening allergic reaction to food and/or drugs\n* history of any other primary malignancy diagnosed within the past 5 years\n* prior radiation to the sites to be treated\n* active infections of the oral cavity'}, 'identificationModule': {'nctId': 'NCT01400620', 'briefTitle': 'Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Izun Pharma Ltd'}, 'officialTitle': 'Phase 2 Study to Evaluate the Safety and Efficacy of IZN-6N4 for the Prevention of Chemo-Radiation-Induced Oral Mucositis in Patients With Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'IOM-HNC-201-IL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active oral rinse', 'description': 'Oral rinse containing botanical extracts', 'interventionNames': ['Drug: IZN-6N4']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo rinse', 'interventionNames': ['Drug: IZN-6N4']}], 'interventions': [{'name': 'IZN-6N4', 'type': 'DRUG', 'description': 'Oral rinse containing 1% botanical extracts, 15 cc rinse 3 times per day, for up to 9 weeks', 'armGroupLabels': ['Active oral rinse', 'Placebo rinse']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health Cancer Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami-Sylvester CCC Clinical Research Services', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Beth Israel - Phillips Ambulatory Care Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Clinical Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center - Beilinson Campus', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Assuta Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izun Pharma Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}