Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Metronidazole
- Chlorhexidine
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
1Case Comprehensive Cancer Center, Cleveland Clinic Foundation44195, ClevelandOhio, United States
Sponsors and collaborators
Case Comprehensive Cancer Center
Lead sponsor
Source ClinicalTrials.gov