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

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Enrolling; Phase 2

Conditions: Head and Neck Carcinoma; Oral Squamous Cell Carcinoma; Head and Neck Cancer; Oral Cancer

Treatments: Other: Chlorhexidine; Drug: Metronidazole

Study type: Interventional

Funder types: Other

Identifiers

NCT06627270

CASE6324

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

10 days of metronidazole and chlorhexidine

Experimental group

Description:

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.

Treatment:

Drug: Metronidazole

Other: Chlorhexidine