Pre-surgery metronidazole and chlorhexidine to lower bacteria in oral cavity tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients with oral cavity squamous cell carcinoma will receive a preoperative regimen of oral metronidazole and chlorhexidine rinses in a single-arm phase II protocol. The study team will measure the absolute amount of bacteria inside the tumor at the time of surgery and analyze changes in the intratumoral bacterial community. Investigators will also profile infiltrating immune cells to see whether microbial modulation is associated with changes in the tumor immune microenvironment. All interventions are given prior to planned curative-intent surgery and tissue sampling occurs at resection.

Why it matters

Who can join: the full rules

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 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's running

• Case Comprehensive Cancer Center, Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Natalie Silver, MD — Case Comprehensive Cancer Center, Cleveland Clinic Foundation
• Study coordinator: Natalie Silver, MD
• Email: silvern@ccf.org
• Phone: 216-219-3267

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.