Actively Recruiting
A Phase II Single-arm Cohort Study Establishing the Effect of Antibiotic Treatment on Intratumoral Bacteria in Surgical Patients With Oral Cancer
Led by Case Comprehensive Cancer Center · Updated on 2026-06-04
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with locally advanced oral squamous cell carcinoma (a type of oral cancer) to evaluate how antibiotics affect bacteria within tumors. The study focuses on patients undergoing surgery and aims to understand whether reducing bacteria in the tumors can change the immune environment and potentially improve treatment outcomes. This is a phase II, single-arm clinical trial exploring the role of bacterial changes in cancer treatment resistance. Participants will receive oral metronidazole (500 mg three times daily) and chlorhexidine mouth rinse (10 ml three times daily) for 10 days before their scheduled surgery. This antibiotic treatment is being assessed for its ability to reduce the amount of bacteria inside the tumors and to observe changes in the bacterial communities and immune cells within the tumor tissue. During the study, researchers will collect tumor samples at baseline and during surgery to measure bacterial levels using a specialized test (16S rRNA qPCR). They will also monitor participants' disease-free survival and overall survival for up to three years following treatment. Participants will be closely monitored for safety and treatment effects throughout the study period, which runs until surgery after the 10-day antibiotic course.
CONDITIONS
Brief Title
Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed squamous cell carcinoma of the oral cavity
- Planned surgery for curative intent
- Age 18 years or older
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Known allergy to metronidazole and/or chlorhexidine
- Severe liver or kidney disease
- Active alcohol use and inability to abstain during 10-day antibiotic treatment
- Recurrent oral cancer after prior radiation or chemoradiation
- Unresectable oral cancer
- Inability to tolerate oral rinse or metronidazole by mouth or feeding tube
- Use of other antibiotics within 30 days prior to enrollment
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 days
Participants receive oral metronidazole and chlorhexidine mouth rinses for 10 days prior to surgery to reduce intratumoral bacteria.
1 baseline visit and 1 pre-surgery visit
Duration - Surgery day and immediate recovery period
Participants undergo surgical resection of oral cancer following antibiotic treatment.
1 surgical visit
Duration - Up to 3 years
Participants are monitored for disease-free survival and overall survival through standard of care surveillance for up to three years after surgery.
Regular visits as per standard of care
Trial Site Locations
Total: 1 location
1
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
N
Natalie Silver, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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