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

Recruiting now · Phase 2

Conditions studied: Oral Squamous Cell Carcinoma, Oral Cancer, Head and Neck Cancer, Head and Neck Carcinoma

In brief

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.

Key facts

Study ID

NCT06627270

Run by

Case Comprehensive Cancer Center

People needed

30

Starts

2025-07-22

Expected to finish

2027-10-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Case Comprehensive Cancer Center, Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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