Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-01-01 @ 5:34 AM
Study NCT ID:
NCT00901732
Status:
UNKNOWN
Last Update Posted:
2009-05-14
First Post:
2009-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for 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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-05-13', 'studyFirstSubmitDate': '2009-05-13', 'studyFirstSubmitQcDate': '2009-05-13', 'lastUpdatePostDateStruct': {'date': '2009-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective is to estimate ht incidence of OM in H&N cancer patients undergoing radiation therapy with or without chemotherapy and/or sensitizer who receive Caphosol.', 'timeFrame': '15 weeks'}], 'secondaryOutcomes': [{'measure': 'The secondary objective of this study is to correlate components of OM data with clinical outcomes (pain, narcotic use, oral intake)', 'timeFrame': '15 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Caphosol', 'Oral Mucositis', 'Eusa Pharma', 'Moffitt Cancer Center'], 'conditions': ['Oral Mucositis']}, 'descriptionModule': {'briefSummary': 'Patients who have been diagnosed with a head and/or neck cancer commonly develop oral mucositis (OM). The purpose of this study is to estimate the effect of Caphosol on OM and to evaluate if Caphosol had any effect on clinical outcomes which include quality of life, oral intake, swallowing function and pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed Head and Neck Cancer patients with planned Radiation therapy\n* Have at least one of 10 pre-defined anatomic mucosal subsites on view\n* Age \\>/= 18 years\n* Life expectancy \\>/= 6 months\n* Planned RT to the head/neck\n* Must be able to perform oral rinse\n\nExclusion Criteria:\n\n* Active infections of oral cavity\n* physiologic condition that precludes the use of an oral rinse\n* Hypersensitivity to Caphosol ingredients\n* Presence of mucosal ulceration at baseline\n* Poorly controlled hypertension, DM or other serious medical/psychiatric illness'}, 'identificationModule': {'nctId': 'NCT00901732', 'briefTitle': 'Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jazz Pharmaceuticals'}, 'officialTitle': 'Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer', 'orgStudyIdInfo': {'id': '603EUSA03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Caphosol', 'type': 'DEVICE', 'otherNames': ['supersaturated solution of calcium and phosphate ions.'], 'description': 'Oral Mouth Rinse'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert Amdur, MD', 'role': 'CONTACT'}, {'name': 'Bridgett Fitzgerald', 'role': 'CONTACT'}], 'facility': 'University of Florida College of Medicine', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andy Trotti, MD', 'role': 'CONTACT', 'phone': '813-745-8424'}, {'name': 'Margaret Lotrimare', 'role': 'CONTACT', 'email': 'margaret.lomartire@moffitt.org', 'phone': '813-745-7223'}], 'facility': 'H. Lee Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kenneth Hu, MD', 'role': 'CONTACT'}], 'facility': 'Beth Israel Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Brizel, MD', 'role': 'CONTACT'}], 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Curtis T Miyamoto, MD', 'role': 'CONTACT'}, {'name': 'Jennifer Curry, RN', 'role': 'CONTACT'}], 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Chambers, MD', 'role': 'CONTACT'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Michael Manyak, MD', 'role': 'CONTACT', 'email': 'michael.manyak@eusapharma.com', 'phone': '609-750-8200'}, {'name': 'Colleen Gramkowski, MST', 'role': 'CONTACT', 'email': 'colleen.gramkowski@eusapharma.com', 'phone': '609-750-8219'}], 'overallOfficials': [{'name': 'Andy M Trotti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center, Tampa Florida'}, {'name': 'David M Brizel, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Duke University, Durham, North Carolina'}, {'name': 'David I Rosenthal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD Anderson Cancer Center, Houston, Texas'}, {'name': 'Mark Chambers, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MD Anderson Cancer Center, Houston, Texas'}, {'name': 'Curtis T Miyamoto, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Temple University Hospital, Philadelphia, PA'}, {'name': 'Kenneth Hu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beth Israel Medical Center, New York, New York'}, {'name': 'Robert Amdur, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Florida, Gainesville, Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jazz Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Michael Manyak, MD / Medical Monitor', 'oldOrganization': 'EUSA Pharma (USA), INc'}}}}