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

NCT06627270 | Recruiting Phase 2 DMC

• 1 other identifier: CASE6324
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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 Carcinoma; Oral Cancer; Head and Neck Cancer; Head and Neck Carcinoma

Keywords

Metronidazole; Chlorhexidine

Outcome Measures

Primary Outcomes (1)

• Change in absolute amount of intraumoral bacteria as quantified by 16S rRNA qPCR

  The difference between pre-treatment and post-treatment tumor bacteria burden will be assessed.

  Baseline, surgery (10 days post intervention)

Secondary Outcomes (3)

• Change in absolute amount of intraumoral bacteria in post treatment participants compared to control patients as quantified by 16S rRNA qPCR

  Baseline, surgery (10 days post intervention)

• Disease-free survival

  Time from date of randomization to recurrence, second primary malignancy, or death, as determined by standard of care surveillance, up to three years.

• Overall Survival

  Time from date of randomization to recurrence, second primary malignancy, or death, as determined by standard of care surveillance, up to three years.

Study Arms (1)

10 days of metronidazole and chlorhexidine

EXPERIMENTAL

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.

Drug: Metronidazole; Other: Chlorhexidine

Interventions

Metronidazole DRUG

Participants will receive metronidazole (500 mg t.i.d. x 10 days)

10 days of metronidazole and chlorhexidine

Chlorhexidine OTHER

Mouth rinse chlorhexidine (10 ml t.i.d. x 10 days)

Also known as: CHX

10 days of metronidazole and chlorhexidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms; Head and Neck Neoplasms

Interventions

Metronidazole; Chlorhexidine

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Officials

• Natalie Silver, MD

  Case Comprehensive Cancer Center, Cleveland Clinic Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalie Silver, MD

CONTACT

216-219-3267; silvern@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 4, 2024
• Study Start: March 11, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available at the time of publication or after 3 years

Locations

US (1)