RECRUITING

Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer

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Conditions

Oral Squamous Cell CarcinomaOral CancerHead and Neck CancerHead and Neck CarcinomaMetronidazoleChlorhexidine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase II Single-arm Cohort Study Establishing the Effect of Antibiotic Treatment on Intratumoral Bacteria in Surgical Patients With Oral Cancer

Quick Facts

Study Start:2025-03-11
Study Completion:2027-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06627270

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically confirmed squamous cell carcinoma of the oral cavity
  2. * Must have planned surgery for curative intent
  3. * Participants ≥ 18 years of age
  4. * Participants must have the ability to understand and the willingness to sign a written informed consent document
  1. * Known allergy to metronidazole and/or chlorhexidine
  2. * Severe liver or kidney disease as determined by history of laboratory tests
  3. * Participants actively drinking alcohol (unable to abstain for the 10 day antibiotic period)
  4. * Recurrent oral cancer after prior radiation or chemoradiation
  5. * Participants with unresectable oral cancer
  6. * Participants unable to tolerate and/or absorb oral medication
  7. * Participants currently or have taken other antibiotics within the prior 60 days
  8. * Participant is pregnant

Contacts and Locations

Study Contact

Natalie Silver, MD
CONTACT
216-219-3267
silvern@ccf.org

Principal Investigator

Natalie Silver, MD
PRINCIPAL_INVESTIGATOR
Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Study Locations (Sites)

Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

  • Natalie Silver, MD, PRINCIPAL_INVESTIGATOR, Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-11
Study Completion Date2027-10-01

Study Record Updates

Study Start Date2025-03-11
Study Completion Date2027-10-01

Terms related to this study

Keywords Provided by Researchers

  • Metronidazole
  • Chlorhexidine

Additional Relevant MeSH Terms

  • Oral Squamous Cell Carcinoma
  • Oral Cancer
  • Head and Neck Cancer
  • Head and Neck Carcinoma