Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-27 @ 4:03 PM
Study NCT ID:
NCT05278260
Status:
COMPLETED
Last Update Posted:
2025-05-14
First Post:
2022-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydrogen-rich Water and Treatment of Mucositis Caused by Radiation Therapy in Head and Neck Cancer Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006859', 'term': 'Hydrogen'}], 'ancestors': [{'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who develop grade 3 oropharyngeal mucositis', 'timeFrame': '3 months after completing radiation therapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['head and neck cancer', 'radiation therapy', 'supportive care'], 'conditions': ['Mucositis Oral']}, 'descriptionModule': {'briefSummary': 'This study explores the effects of hydrogen-rich water on alleviating the radiation-induced acute mucositis in head and neck cancer patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of a biopsy proven head and neck cancer, early or advanced stage, primary or recurrent tumor,\n* Planning to receive daily fractionated radiotherapy for over 4 weeks' duration\n* Karnofsky Performance Score (KPS) of at least 70\n* Able to describe pain\n* Able to swallow food and water\n* Able to sign consent\n\nExclusion Criteria:\n\n\\-"}, 'identificationModule': {'nctId': 'NCT05278260', 'briefTitle': 'Hydrogen-rich Water and Treatment of Mucositis Caused by Radiation Therapy in Head and Neck Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'Hydrogen Rich Water to Mitigate Acute Mucositis During Radiation Therapy', 'orgStudyIdInfo': {'id': 'SBU-HYDROGEN-HN-RT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Dietary Supplement: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Active', 'interventionNames': ['Dietary Supplement: Hydrogen tablets']}], 'interventions': [{'name': 'Hydrogen tablets', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will drink up to 1000 ml (34 fl. oz.) of water daily supplemented with a tablet that releases molecular hydrogen, for the duration of the radiation therapy', 'armGroupLabels': ['Active']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will drink up to 1000 ml (34 fl. oz.) of water daily supplemented with a tablet that does not release any molecular hydrogen, for the duration of the radiation therapy', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook Cancer Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'overallOfficials': [{'name': 'Kartik Mani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stony Brook University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stony Brook University', 'class': 'OTHER'}, 'collaborators': [{'name': 'DrinkHRW', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Survivorship Program Coordinator - Department of Radiation Oncology', 'investigatorFullName': 'Clare Moran', 'investigatorAffiliation': 'Stony Brook University'}}}}