Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT00699569
Status:
UNKNOWN
Last Update Posted:
2008-07-23
First Post:
2008-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyperimmune Colostrum and Oral Mucositis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D052016', 'term': 'Mucositis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-07-22', 'studyFirstSubmitDate': '2008-06-17', 'studyFirstSubmitQcDate': '2008-06-17', 'lastUpdatePostDateStruct': {'date': '2008-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hyperimmune colostrum', 'mucositis'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'To study the effect of daily intake of hyperimmune colostrum on prevention and treatment of oral mucositis in patients with head and neck cancer undergoing high-dose radiation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with: naso-pharynx, oral cavity, oro-pharynx and advanced localized laryngeal cancer.\n\nExclusion Criteria:\n\n* Other tumors\n* Non-epithelial tumors\n* Pregnancy\n* Poor functional status'}, 'identificationModule': {'nctId': 'NCT00699569', 'acronym': 'Mucositis', 'briefTitle': 'Hyperimmune Colostrum and Oral Mucositis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'The Effect of Hyperimmune Colostrum on Radiation-Induce Oral Mucositis of Patients With Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'TASMC-08-NV-248'}, 'secondaryIdInfos': [{'id': '0248-08-TLV'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients receiving active investigational product', 'interventionNames': ['Dietary Supplement: hyperimmune colostrum']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Patients receiving Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'hyperimmune colostrum', 'type': 'DIETARY_SUPPLEMENT', 'description': 'hyperimmune colostrum', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'contacts': [{'name': "Nachum Vaisman, Prof'", 'role': 'CONTACT', 'email': 'vaisman@tasmc.health.gov.il', 'phone': '972-3-697-4807'}, {'name': "Nachum Vaisman, Prof'", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': "Nachum Vaisman, Prof'", 'role': 'CONTACT', 'email': 'vaisman@tasmc.health.gov.il', 'phone': '972-3-697-4807'}], 'overallOfficials': [{'name': "Nachum Vaisman, Prof'", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel-Aviv Sourasky Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': "Nachum Vaisman Prof'", 'oldOrganization': 'Tel-Aviv Sourasky Medical Center'}}}}