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

Conditions

Oral Squamous Cell CarcinomaOral CancerHead and Neck CancerHead and Neck Carcinoma
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Related Conditions:

Oral Squamous Cell CarcinomaOral CancerHead and Neck CancerHead and Neck Carcinoma

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Oral Squamous Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Cleveland

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Case Comprehensive Cancer Center,

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

Study Record Dates

2027-10-01