NCT06627270 Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer
| NCT ID | NCT06627270 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Case Comprehensive Cancer Center |
| Condition | Oral Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-07-22 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-07-22 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Natalie Silver, MD
PRINCIPAL INVESTIGATOR
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Frequently Asked Questions
Who can join the NCT06627270 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oral Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06627270 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06627270 currently recruiting?
Yes, NCT06627270 is actively recruiting participants. Contact the research team at silvern@ccf.org for enrollment information.
Where is the NCT06627270 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06627270 clinical trial?
NCT06627270 is sponsored by Case Comprehensive Cancer Center. The principal investigator is Natalie Silver, MD at Case Comprehensive Cancer Center, Cleveland Clinic Foundation. The trial plans to enroll 30 participants.