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Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer

RecruitingPhase 2Ages 18 Years - anyAllCase Comprehensive Cancer Center
NCT06627270 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Metronidazole
  • Chlorhexidine
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Where

1 site
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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