Clinical trial · Interventional
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
NCT06627270CI-TRIAL-00120750recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chlorhexidine | Other | — | UNRESOLVED |
| Metronidazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 10 days of metronidazole and chlorhexidine
- description
- 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.
- interventionNames
- Drug: Metronidazole
- Other: Chlorhexidine
Primary outcomes (1)
- measure
- Change in absolute amount of intraumoral bacteria as quantified by 16S rRNA qPCR
- timeFrame
- Baseline, surgery (10 days post intervention)
- description
- The difference between pre-treatment and post-treatment tumor bacteria burden will be assessed.
Secondary outcomes (3)
- measure
- Change in absolute amount of intraumoral bacteria in post treatment participants compared to control patients as quantified by 16S rRNA qPCR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.