Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627270
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Single-arm Cohort Study Establishing the Effect of Antibiotic Treatment on Intratumoral Bacteria in Surgical Patients With Oral Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None