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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT06627270
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metronidazole — DRUG
    Participants will receive metronidazole (500 mg t.i.d. x 10 days)
  • Chlorhexidine — OTHER
    Mouth rinse chlorhexidine (10 ml t.i.d. x 10 days)

Study Details

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.

Key Dates

Start date
Mar 11, 2025
Status verified
Jun 2026
Primary completion
Oct 1, 2026
Completion
Oct 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Change in absolute amount of intraumoral bacteria as quantified by 16S rRNA qPCR [ Time Frame: Baseline, surgery (10 days post intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Comprehensive Cancer Center, Cleveland Clinic FoundationClevelandOhio44195
Natalie Silver, MD

Find similar trials in Cleveland, OH

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Case Comprehensive Cancer Center, Cleveland Clinic Foundation· Cleveland, OH

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