RecruitingPhase 2NCT06627270
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
Sponsor
Case Comprehensive Cancer Center
Enrollment
30 participants
Start Date
Mar 11, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Pathologically confirmed squamous cell carcinoma of the oral cavity
- Must have planned surgery for curative intent
- Participants ≥ 18 years of age
- Participants must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria8
- Known allergy to metronidazole and/or chlorhexidine
- Severe liver or kidney disease as determined by history of laboratory tests
- Participants actively drinking alcohol (unable to abstain for the 10 day antibiotic period)
- Recurrent oral cancer after prior radiation or chemoradiation
- Participants with unresectable oral cancer
- Participants unable to tolerate oral rinse or unable to have metronidazole administered by mouth or by feeding tube
- Participants currently or have taken other antibiotics within the prior 30 days
- Participant is pregnant
Interventions
DRUGMetronidazole
Participants will receive metronidazole (500 mg t.i.d. x 10 days)
OTHERChlorhexidine
Mouth rinse chlorhexidine (10 ml t.i.d. x 10 days)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06627270
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