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

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

NCT ID: NCT06627270

Condition: Oral Squamous Cell Carcinoma
Oral Cancer
Head and Neck Cancer
Head and Neck Carcinoma

Conditions: Official terms:
Carcinoma
Mouth Neoplasms
Lip Neoplasms
Squamous Cell Carcinoma of Head and Neck
Chlorhexidine
Metronidazole

Conditions: Keywords:
Metronidazole
Chlorhexidine

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Metronidazole
Description: Participants will receive metronidazole (500 mg t.i.d. x 10 days)
Arm group label: 10 days of metronidazole and chlorhexidine

Intervention type: Other
Intervention name: Chlorhexidine
Description: Mouth rinse chlorhexidine (10 ml t.i.d. x 10 days)
Arm group label: 10 days of metronidazole and chlorhexidine

Other name: CHX

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.

Detailed 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Address:
City: Cleveland
Zip: 44195
Country: United States

Contact:
Last name: Natalie Silver, MD

Start date: December 1, 2024

Completion date: October 1, 2027

Lead sponsor:
Agency: Case Comprehensive Cancer Center
Agency class: Other

Source: Case Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06627270