Antibiotic Treatment to Reduce Intratumoral Bacteria before Surgery in Patients with Oral Cavity Cancer

PRIMARY OBJECTIVE:

I. To demonstrate the effect of antibiotic treatment on alteration of total intratumoral bacteria (as measured by quantitative polymerase chain reaction [qPCR] quantification of pre- and post- treatment formalin fixed paraffin embedded [FFPE] tissue samples) in surgical patients with oral cancer.

SECONDARY OBJECTIVES:

I. Compare tumor bacteria burden (TBB) in post-antibiotic treatment trial participants with disease-site, gender, smoking status, and age-matched control patients.

II. Investigate the relationship between TBB and disease-free and overall survival.

CORRELATIVE OBJECTIVES:

I. Characterize the tumor infiltrating immune response to antibiotic treatment, focusing on T cells and neutrophils/polymorphonuclear myeloid-derived suppressor cells (PMN-MDSCs).

II. Establish the intratumoral bacterial community alterations pre- and post- antibiotic treatment.

III. Understand the changes in cytokine gene expression in response to antibiotics.

IV. Understand the microbial and/or immunologic changes in patient stool, saliva, blood and tissue swabs in response to antibiotic treatment.

OUTLINE:

Patients receive metronidazole orally (PO) three times daily (TID) and use chlorhexidine oral rinse TID for 10 days prior to standard of care (SOC) surgery. Patients also undergo collection of blood, oral swab, and tissue samples at screening and on study.

After completion of study treatment, patients are followed up for 14 days post-operatively and then by medical record review every 3 months for 2 years and then every 6 months for 3 years.