Phase II Study on the Effect of Antibiotics Metronidazole and Chlorhexidine on Bacteria in Tumors of Oral Cancer Surgery Patients

What this Trial Is About

Researchers are investigating the effects of antibiotics and oral rinses on the bacteria inside tumors of patients with oral cancer undergoing surgery. This phase II single-arm study focuses on patients with locally advanced, non-HPV associated head and neck squamous cell carcinoma. The research aims to understand how reducing bacteria in tumors might influence the immune environment and potentially overcome treatment resistance. Participants will receive a 10-day treatment of metronidazole 500 mg three times daily and chlorhexidine mouth rinse 10 ml three times daily before their surgical tumor removal. The study evaluates changes in the amount and type of bacteria within the tumors and examines immune cell changes due to this treatment. During the study, participants will be monitored from baseline through surgery, 10 days after the intervention. Researchers will measure bacterial levels using specific genetic tests and assess disease-free survival and overall survival up to three years. Participants response to treatment and safety will be closely followed during this period.

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