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

RECRUITINGPhase 2Sponsored by Case Comprehensive Cancer Center
Actively Recruiting
PhasePhase 2
SponsorCase Comprehensive Cancer Center
Started2025-03-11
Est. completion2026-10-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06627270

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

Age: 18 Years+Healthy volunteers accepted
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 and/or absorb oral medication
* Participants currently or have taken other antibiotics within the prior 60 days
* Participant is pregnant

Conditions5

CancerHead and Neck CancerHead and Neck CarcinomaOral CancerOral Squamous Cell Carcinoma

Locations1 site

Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Natalie Silver, MD

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