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NCT Number: NCT06627270

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

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.

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Key information

Conditions

Oral Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Cancer Head and Neck Carcinoma Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oral Cancer Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Natalie Silver, MD

CONTACT

About this study

The prognosis for patients with locally advanced, non-Human Papillomavirus (HPV) associated head and neck squamous cell carcinoma (HNSCC) remains poor. The immunosuppressive tumor immune microenvironment in HNSCC presents a significant barrier to both conventional and immune-based therapies. Recent studies have indicated that dysbiotic oral microbiota, particularly in the context of periodontal disease, can contribute to chronic oral mucosal inflammation and the recruitment of suppressive immune cell infiltrates. Bacterial-induced chronic inflammation may play a crucial role in treatment resistance in HNSCC. Understanding the impact of microbial modulation on the tumor immune microenvironment in HNSCC could lead to the identification of novel therapeutic targets.

In this single-arm phase II clinical trial, oral cancer patients will be treated with oral metronidazole and CHX rinses prior to surgery. Investigator will assess the ability for the treatment to reduce the absolute amount of intratumoral bacteria and evaluate changes in the intratumoral bacterial community and infiltrating immune cells.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Metronidazole

Drug

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

Chlorhexidine

Other

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

Other names: CHX

Primary outcomes

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

    Time frame: Baseline, surgery (10 days post intervention)

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

Secondary outcomes

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

    Time frame: Baseline, surgery (10 days post intervention)

  2. Disease-free survival

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

  3. Overall Survival

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

Study contacts

Contact information is provided by the study sponsor or research team.

Natalie Silver, MD

CONTACT

[email protected]

216-219-3267

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 4, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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