[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615070":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":63,"collaborators":20,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":20,"enrollmentInfo":75,"targetDuration":20,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Woman's","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexamethasone Mouthwash Intervention Group","EXPERIMENTAL","Participants in this arm will receive an alcohol-free dexamethasone mouthwash (0.5 mg per 5 mL solution). They will be instructed to swish and spit 10 mL of the mouthwash for 2 minutes, four times daily, beginning in the first week of chemotherapy. Mouthwash use will continue for at least 8 weeks.",[13],"Drug: Dexamethasone Mouthwash",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Dexamethasone Mouthwash","Participants will use 10 mL of alcohol-free dexamethasone mouthwash (0.5 mg per 5 mL) as a swish-and-spit rinse for 2 minutes, four times per day. Use will begin during the first week of chemotherapy and continue for at least 8 weeks.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Ashley R Edwards, PhD","Woman's Hospital, Louisiana","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","225-421-9185","ashley.edwards@womans.org",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Ericka Seidemann, MA","225-231-5296","ERICKA.SEIDEMANN@womans.org",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Woman's Hospital","RECRUITING","Baton Rouge","Louisiana","70817","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-91.18747,30.44332,{"lat":48,"lon":47},[51,52,53,54,56,59,61],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"name":55,"role":25,"phone":20,"phoneExt":20,"email":20},"Mary R Salario, BSN, RN, CRN",{"name":57,"role":58,"phone":20,"phoneExt":20,"email":20},"Lauren A Zatarain, MD","SUB_INVESTIGATOR",{"name":60,"role":58,"phone":20,"phoneExt":20,"email":20},"Brooke Coogan, MS",{"name":62,"role":58,"phone":20,"phoneExt":20,"email":20},"Elizabeth F Sutton, PhD",{"type":64,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100615070","phase-4-using-a-steroid-mouthwash-to-prevent-mouth-sores-during-chemotherapy-100615070",false,"NCT07287826","Using a Steroid Mouthwash to Prevent Mouth Sores During Chemotherapy","Study for Dexamethasone Mouthwash in Lowering Episodes of Oral Mucositis Among Patients With Cancer: The SMILE Study","SMILE","Inclusion criteria:\n\n* ≥18 years old\n* Confirmed cancer diagnosis\n* Scheduled to receive or receiving chemotherapy known to be associated with oral mucositis (e.g., anthracyclines and taxanes)\n* Ability to provide informed consent\n* Ability to comply with study procedures\n\nExclusion criteria:\n\n* Current tobacco usage or usage within the past 6 weeks.\n* HIV\u002FAIDS\n* Gastrointestinal disorder (such as Crohn's disease, ulcerative colitis, or celiac disease)\n* History of cold sores (herpes simplex virus)\n* Herpes zoster (oral shingles) within the past 6 weeks\n* Active oral infections at the time of enrollment (e.g., candidiasis)\n* Known sensitivity or allergy to dexamethasone\n* Inability to self-administer or tolerate mouthwash protocol\n* Concurrent enrollment in conflicting clinical trials\n* Existing oral ulcers or oral mucositis at enrollment\n* Pregnant\n* Uncontrolled diabetes mellitus as defined by HbA1c unknown or \\>8% in the past 3 months despite adequate therapy","ALL","18 Years",{"count":76,"type":77},45,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","The goal of this clinical trial is to learn if a steroid mouthwash (dexamethasone) can prevent mouth sores caused by chemotherapy in adults with cancer. The main questions it aims to answer are:\n\nDoes using dexamethasone mouthwash before and during chemotherapy lower the chance of getting moderate to severe mouth sores?\n\nCan this approach reduce pain and improve comfort during chemotherapy?\n\nResearchers will compare patients using the mouthwash to a historical group of patients who received similar chemotherapy but did not use the mouthwash, to see if the mouthwash helps prevent mouth sores.\n\nParticipants will:\n\nUse a steroid mouthwash (4 times daily) for up to 8 weeks during chemotherapy\n\nComplete a short weekly survey about mouth discomfort during infusion visits",[83],"Oral Mucositis Due to Chemotherapy",[85],"oral mucositis","2026-06-22",{"date":88,"type":89},"2026-06-25","ACTUAL",{"date":91,"type":89},"2026-04-02",{"date":93,"type":77},"2028-01",{"name":5,"class":6},1]