Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer
Launched by CASE COMPREHENSIVE CANCER CENTER · Oct 2, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking to understand how certain antibiotics, specifically metronidazole, and an oral mouth rinse called chlorhexidine, can affect the bacteria found in tumors of patients with oral cancer. The main goal is to see if these treatments can help reduce the amount of bacteria in tumors before patients undergo surgery, which is often needed to treat oral cancer.
To participate in this trial, you must be at least 18 years old and have a confirmed diagnosis of squamous cell carcinoma in the mouth, with surgery planned for treatment. It's important that you do not have certain conditions, like severe liver or kidney disease, and you should not be allergic to the medications used in this study. If eligible, you can expect to take the antibiotics and mouth rinse for a short period before your surgery, and you'll be closely monitored by the medical team throughout the process. This research could provide valuable insights into how to improve treatment outcomes for patients with oral cancer.
Gender
ALL
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 and/or absorb oral medication
- • Participants currently or have taken other antibiotics within the prior 60 days
- • Participant is pregnant
About Case Comprehensive Cancer Center
Case Comprehensive Cancer Center is a leading academic research institution dedicated to advancing cancer care through innovative clinical trials and cutting-edge research. As a National Cancer Institute-designated Comprehensive Cancer Center, it integrates multidisciplinary approaches to cancer prevention, diagnosis, and treatment, fostering collaboration among clinicians, researchers, and patients. The center is committed to translating scientific discoveries into effective therapies, enhancing patient outcomes, and contributing to the global body of cancer knowledge. With a robust portfolio of clinical trials, Case Comprehensive Cancer Center aims to address the unmet needs of cancer patients and drive progress in the fight against cancer.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Patients applied
Trial Officials
Natalie Silver, MD
Principal Investigator
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported