What this study is
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.
What's being tested
- Metronidazole
Intervention · DRUG
Participants will receive metronidazole (500 mg t.i.d. x 10 days)
- Chlorhexidine
Intervention · OTHER
Mouth rinse chlorhexidine (10 ml t.i.d. x 10 days)
Study details
- Official title
- 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
- Conditions
- Oral Squamous Cell Carcinoma · Oral Cancer · Head and Neck Cancer · Head and Neck Carcinoma
- Enrolling
- 30 people
- Starts
- 2025-07-22
- Est. completion
- 2027-10-01
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openCase Comprehensive Cancer Center, Cleveland Clinic Foundation
Cleveland, Ohio, United States
- Natalie Silver, MD · Contact
Recruiting
Study team
Sponsor
Case Comprehensive Cancer Center
Study ID CASE6324
Principal investigator
Natalie Silver, MD
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.