Recruiting
Phase 2

Metronidazole & CHX

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT06627270

Conditions

Oral Squamous Cell Carcinoma

Oral Cancer

Head and Neck Cancer

Head and Neck Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Metronidazole

Chlorhexidine

Study Details

Brief 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.

Conditions

Oral Squamous Cell Carcinoma

Oral Cancer

Head and Neck Cancer

Head and Neck Carcinoma

Study ID

NCT06627270

Start date

Jul 22, 2025

Status verified date

Aug, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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 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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 10 days of metronidazole and chlorhexidine

Participants will receive metronidazole (500 mg t.i.d. x 10 days) and chlorhexidine (10 ml t.i.d. x 10 days) prior to surgical resection.

Interventions

Metronidazole

Participants will receive metronidazole (500 mg t.i.d. x 10 days)

Chlorhexidine

Mouth rinse chlorhexidine (10 ml t.i.d. x 10 days)

Primary outcome measure

  • Change in absolute amount of intraumoral bacteria as quantified by 16S rRNA qPCR [ Time Frame: Baseline, surgery (10 days post intervention) ]

Central Contacts and Locations

Central contacts

Natalie Silver, MD

216-219-3267silvern@ccf.org

Locations

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Metronidazole
  • Chlorhexidine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-06.