[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473201":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":56,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care + virgin coconut oil","EXPERIMENTAL","Arm A: Standard of care + virgin coconut oil",[13],"Drug: Virgin Coconut Oil",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","NO_INTERVENTION","Arm B: Standard of care",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Virgin Coconut Oil","Standard of care with the addition of virgin coconut oil mouth rinse",[9],[26],{"name":27,"affiliation":5,"role":28},"Courtney Huddle, MSN, RDN, CSPCC, LDN","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Sceria Jenkins, RN","CONTACT","980-442-2323","sceria.jenkins@atriumhealth.org",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Marithza Amaya","980-442-0530","marirthza.amaya@atriumhealth.org",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Atrium Health Levine Children's Hospital","RECRUITING","Charlotte","North Carolina","28203","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-80.84313,35.22709,{"lat":52,"lon":51},[55],{"name":27,"role":28,"phone":18,"phoneExt":18,"email":18},{"type":57,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100473201","phase-2-coconut-oil-to-prevent-mouth-sores-in-pediatric-patients-receiving-high-dose-chemotherapy-100473201",false,"NCT05441813","Coconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy","A Randomized, Open-label Study of Coconut Oil Mouth Rinse for Prophylaxis of Severe Oral Mucositis in Pediatric Patients Receiving Myeloablative Conditioning Regimens","Inclusion Criteria:\n\nSubject must meet all the following applicable inclusion criteria to participate in this study:\n\n1. Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian.\n2. Age greater than or equal to 7 years to 26 years at the time of consent\n3. Patients planning to undergo myeloablative conditioning regimens in preparation for HSCT\n4. ECOG Performance Status of less than or equal to 2 or Lansky\u002FKarnofsky Performance Status of greater than or equal to 50 within 7 days prior to date of enrollment.\n5. No evidence of mouth lesions at time of enrollment\n6. Ability of the subject and parent\u002Fcaregiver to understand and comply with study procedures for the entire length of the study\n7. Able and willing to swish\u002Fspit the oral formulation\n\nExclusion Criteria:\n\nSubjects meeting any of the criteria below may not participate in the study:\n\n1. Allergy to tree nuts\n2. Planned discharge home prior to engraftment\n3. Using coconut oil mouth rinses within 30 days prior to enrollment\n4. Using additional mouthcare regimens, other than those allowed in the institutional SOP, prior to admission with a plan to continue use during admission\n5. Patient has undergone HSCT within the last 90 days prior to admission","ALL","7 Years","26 Years",{"count":69,"type":70},60,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","The purpose of this study is to learn if virgin coconut oil (VCO) mouth rinse can help prevent oral mucositis. The Study Investigator will compare standard of care mucositis prevention rinses with the VCO mouth rinse added to the standard of care mucositis prevention rinses. The severity of oral mucositis between the 2 groups will be evaluated. Some of the standard of care rinses that can be used to prevent mucositis are normal saline, Benadryl (diphenhydramine), Mylanta, lidocaine, or other combinations.",[76],"Oral Mucositis",[78,22,79],"Prevention","Mouth Rinse","2026-01-06",{"date":82,"type":83},"2026-01-07","ACTUAL",{"date":85,"type":83},"2023-02-15",{"date":87,"type":70},"2036-07",{"name":5,"class":6},1]