Case Comprehensive Cancer Center
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.
The prognosis for patients with locally advanced, non-Human Papillomavirus (HPV) associated head and neck squamous cell carcinoma (HNSCC) remains poor. The immunosuppressive tumor immune microenvironment in HNSCC presents a significant barrier to both conventional and immune-based therapies. Recent studies have indicated that dysbiotic oral microbiota, particularly in the context of periodontal disease, can contribute to chronic oral mucosal inflammation and the recruitment of suppressive immune cell infiltrates. Bacterial-induced chronic inflammation may play a crucial role in treatment resis…
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 will receive metronidazole (500 mg t.i.d. x 10 days)
Mouth rinse chlorhexidine (10 ml t.i.d. x 10 days)
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