NCT06627270RecruitingPhase 2
Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer
A Phase II Single-arm Cohort Study Establishing the Effect of Antibiotic Treatment on Intratumoral Bacteria in Surgical Patients With Oral Cancer
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 30 Sept 2024
- Start date
- 22 Jul 2025
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Case Comprehensive Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT06627270
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 22 Jul 2025 to the primary completion date, 1 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recurrent oral cancer after prior radiation or chemoradiation
- Participants currently or have taken other antibiotics within the prior 30 days
Other illness
- Known allergy to metronidazole and/or chlorhexidine
- Participants with unresectable oral cancer
Lab values
- Severe liver or kidney disease as determined by history of laboratory tests
Other
- Participants actively drinking alcohol (unable to abstain for the 10 day antibiotic period)
- Participants unable to tolerate oral rinse or unable to have metronidazole administered by mouth or by feeding tube
- Participant is pregnant
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Case Comprehensive Cancer Center, Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.