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

Plain Language Summary

Simplified for easier understanding

This study investigates whether a short course of antibiotics (metronidazole) and an antiseptic mouth rinse (chlorhexidine) given before surgery can change the bacteria living inside oral cancer tumors, and whether that change affects surgical outcomes and cancer biology. **You may be eligible if...** - You are 18 or older - You have been diagnosed with squamous cell carcinoma of the mouth (oral cavity) - You are scheduled to have surgery with the intent to cure - You are able to understand and sign an informed consent form **You may NOT be eligible if...** - You have a known allergy to metronidazole or chlorhexidine - You have severe liver or kidney disease - You are actively drinking alcohol or cannot abstain during the 10-day antibiotic period - Your oral cancer is a recurrence after prior radiation or chemoradiation - Your cancer is not surgically removable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Cleveland, Ohio, United States

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NCT06627270


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