A Phase II Single-arm Cohort Study Establishing the Effect of Antibiotic Treatment on Intratumoral Bacteria in Surgical Patients With Oral Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in absolute amount of intraumoral bacteria as quantified by 16S rRNA qPCR
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
10 days of metronidazole and chlorhexidine
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.
干预措施: Chlorhexidine (Other)
10 days of metronidazole and chlorhexidine
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.
干预措施: Metronidazole (Drug)
结局指标
主要结局
Change in absolute amount of intraumoral bacteria as quantified by 16S rRNA qPCR
时间窗: Baseline, surgery (10 days post intervention)
The difference between pre-treatment and post-treatment tumor bacteria burden will be assessed.
次要结局
- 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.)
- 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.)