[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564291":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":33,"locations":38,"responsibleParty":54,"collaborators":21,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":21,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":21,"enrollmentInfo":65,"targetDuration":21,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":77,"overallStatus":40,"whyStopped":21,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Case Comprehensive Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"10 days of metronidazole and chlorhexidine","EXPERIMENTAL","Participants will receive metronidazole (500 mg t.i.d. x 10 days) and chlorhexidine (10 ml t.i.d. x 10 days) prior to surgical resection.",[13,14],"Drug: Metronidazole","Other: Chlorhexidine",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Metronidazole","Participants will receive metronidazole (500 mg t.i.d. x 10 days)",[9],null,{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"Chlorhexidine","Mouth rinse chlorhexidine (10 ml t.i.d. x 10 days)",[9],[27],"CHX",[29],{"name":30,"affiliation":31,"role":32},"Natalie Silver, MD","Case Comprehensive Cancer Center, Cleveland Clinic Foundation","PRINCIPAL_INVESTIGATOR",[34],{"name":30,"role":35,"phone":36,"phoneExt":21,"email":37},"CONTACT","216-219-3267","silvern@ccf.org",[39],{"facility":31,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-81.69541,41.4995,{"lat":50,"lon":49},[53],{"name":30,"role":35,"phone":21,"phoneExt":21,"email":21},{"type":55,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100564291","phase-2-antibiotic-treatment-effects-on-intratumoral-bacteria-modulation-in-surgical-patients-with-oral-cancer-100564291",false,"NCT06627270","Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer","A Phase II Single-arm Cohort Study Establishing the Effect of Antibiotic Treatment on Intratumoral Bacteria in Surgical Patients With Oral Cancer","Inclusion Criteria:\n\n* Pathologically confirmed squamous cell carcinoma of the oral cavity\n* Must have planned surgery for curative intent\n* Participants ≥ 18 years of age\n* Participants must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Known allergy to metronidazole and\u002For chlorhexidine\n* Severe liver or kidney disease as determined by history of laboratory tests\n* Participants actively drinking alcohol (unable to abstain for the 10 day antibiotic period)\n* Recurrent oral cancer after prior radiation or chemoradiation\n* Participants with unresectable oral cancer\n* Participants unable to tolerate oral rinse or unable to have metronidazole administered by mouth or by feeding tube\n* Participants currently or have taken other antibiotics within the prior 30 days\n* Participant is pregnant","ALL","18 Years",{"count":66,"type":67},30,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","The goal of this phase II single arm clinical study is to evaluate the effect of antibiotics (metronidazole) and oral chlorhexidine (CHX) in reducing the bacteria load within tumors of patients undergoing surgery for oral cancer.",[73,74,75,76],"Oral Squamous Cell Carcinoma","Oral Cancer","Head and Neck Cancer","Head and Neck Carcinoma",[18,23],"2026-06-03",{"date":80,"type":81},"2026-06-04","ACTUAL",{"date":83,"type":81},"2025-03-11",{"date":85,"type":67},"2027-10-01",{"name":5,"class":6},1]