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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole | Drug | Participants will receive metronidazole (500 mg t.i.d. x 10 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalie Silver, MD | Contact | 216-219-3267 | silvern@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Natalie Silver, MD | Case Comprehensive Cancer Center, Cleveland Clinic Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Comprehensive Cancer Center, Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
RNAseq results will be shared upon publication, not patient identifiers will be shared
Data will be available at the time of publication or after 3 years
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| Chlorhexidine | Other | Mouth rinse chlorhexidine (10 ml t.i.d. x 10 days) |
|
|
| 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. |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009062 | Mouth Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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