Antibiotics and Mouthwash for Oral Cancer

Overseen By Natalie Silver, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Other antibiotics

Disqualifiers: Severe liver, kidney disease, alcohol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 10 days

30 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you have taken other antibiotics in the last 60 days.

What data supports the effectiveness of the drug Metronidazole and related treatments for oral cancer?

There is no direct evidence from the provided research articles about the effectiveness of Metronidazole for oral cancer. However, some studies suggest that imidazole antibiotics, a category that includes Metronidazole, may help reduce the intensity of oral mucositis (painful inflammation and ulceration in the mouth) caused by cancer treatments. ^{1 2 3 4 5}

How is the drug Metronidazole unique in treating oral cancer?

Metronidazole is unique for oral cancer treatment because it is an antibiotic that targets bacterial infections, which may help reduce inflammation and infection in the mouth, unlike traditional cancer treatments that focus directly on killing cancer cells. ^{3 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Natalie Silver, MD

Principal Investigator

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Eligibility Criteria

This trial is for patients with oral cancer, specifically those with lip tumors or squamous cell carcinoma in the head and neck area. Participants must be scheduled for surgery. There are specific inclusion and exclusion criteria that determine who can participate, but these have not been detailed here.

Inclusion Criteria

Participants must have the ability to understand and the willingness to sign a written informed consent document

My cancer is a type of squamous cell found in the mouth.

I am scheduled for surgery to remove my cancer.

Exclusion Criteria

Known allergy to metronidazole and/or chlorhexidine

Participants actively drinking alcohol (unable to abstain for the 10 day antibiotic period)

I have taken antibiotics in the last 60 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive metronidazole and chlorhexidine rinses for 10 days prior to surgery

10 days

Daily administration

Surgery

Surgical resection of oral cancer is performed

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in intratumoral bacteria and immune cell infiltration

4 weeks

Treatment Details

Interventions

• Metronidazole

Trial Overview The study is testing the effects of an antibiotic called metronidazole and a mouthwash containing chlorhexidine on reducing bacteria in tumor tissues of oral cancer patients during surgery.

Participant Groups

Group I: 10 days of metronidazole and chlorhexidine Experimental Treatment 2 Interventions

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.

Metronidazole is already approved in United States, European Union, India, Canada for the following indications:

Approved in United States as Flagyl for:

• Pelvic inflammatory disease
• Endocarditis
• Bacterial vaginosis
• Dracunculiasis
• Giardiasis
• Trichomoniasis
• Amebiasis
• Clostridioides difficile colitis

Approved in European Union as Flagyl for:

• Pelvic inflammatory disease
• Endocarditis
• Bacterial vaginosis
• Dracunculiasis
• Giardiasis
• Trichomoniasis
• Amebiasis
• Clostridioides difficile colitis

Approved in India as Metrogyl for:

• Pelvic inflammatory disease
• Endocarditis
• Bacterial vaginosis
• Dracunculiasis
• Giardiasis
• Trichomoniasis
• Amebiasis
• Clostridioides difficile colitis

Approved in Canada as Flagyl for:

• Pelvic inflammatory disease
• Endocarditis
• Bacterial vaginosis
• Dracunculiasis
• Giardiasis
• Trichomoniasis
• Amebiasis
• Clostridioides difficile colitis

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Meta-analysis of randomized controlled trials of the efficacy of propolis mouthwash in cancer therapy-induced oral mucositis. [2018]

2. Greece pubmed.ncbi.nlm.nih.gov

Cancer treatment-induced oral mucositis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of the effectiveness of 3 commonly used mouthwashes to treat chemotherapy-induced mucositis. [2022]

4. India pubmed.ncbi.nlm.nih.gov

The effect of three mouthwashes on radiation-induced oral mucositis in patients with head and neck malignancies: a randomized control trial. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

The antimicrobial effect of Iseganan HCl oral solution in patients receiving stomatotoxic chemotherapy: analysis from a multicenter, double-blind, placebo-controlled, randomized, phase III clinical trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of antiseptic mouthwashes on some clinical and microbiological findings in the mouths of lymphoma patients receiving cytostatic drugs. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Effect of triphala mouthrinse on plaque and gingival inflammation: A systematic review and meta-analysis of randomized controlled trials. [2022]

8. Thailand pubmed.ncbi.nlm.nih.gov

Randomized DoubleBlind PlaceboControlled Trial of Propolis for Oral Mucositis in Patients Receiving Chemotherapy for Head and Neck Cancer. [2017]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A comparison between zinc sulfate and chlorhexidine gluconate mouthwashes in the prevention of chemotherapy-induced oral mucositis. [2022]