Clinical trial NCT06627270: Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer
Official title: A Phase II Single-arm Cohort Study Establishing the Effect of Antibiotic Treatment on Intratumoral Bacteria in Surgical Patients With Oral Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Oral Squamous Cell Carcinoma
Oral Cancer
Head and Neck Cancer
Head and Neck Carcinoma
Keywords: Metronidazole
Chlorhexidine
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Change in absolute amount of intraumoral bacteria as quantified by 16S rRNA qPCR
timeFrame: Baseline, surgery (10 days post intervention)
Secondary outcomes:
measure: Change in absolute amount of intraumoral bacteria in post treatment participants compared to control patients as quantified by 16S rRNA qPCR
timeFrame: Baseline, surgery (10 days post intervention)
measure: Disease-free survival
timeFrame: Time from date of randomization to recurrence, second primary malignancy, or death, as determined by standard of care surveillance, up to three years.
measure: Overall Survival
timeFrame: Time from date of randomization to recurrence, second primary malignancy, or death, as determined by standard of care surveillance, up to three years.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center, Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center, Cleveland Clinic Foundation
name: Natalie Silver, MD
role: PRINCIPAL_INVESTIGATOR
References: