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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether antibiotics (metronidazole) and a special mouthwash (chlorhexidine) can reduce bacteria in tumors for individuals undergoing surgery for oral cancer. The goal is to determine if this combination can enhance surgical effectiveness by lowering bacterial load. The trial seeks participants with confirmed oral squamous cell carcinoma who are scheduled for surgery. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that metronidazole, one of the treatments in this trial, has been studied for its effects on cancer. In some animal studies, it caused tumors in mice and rats. However, short-term use in humans has not been linked to a higher cancer risk.

Chlorhexidine, the mouthwash used in this trial, is a common antiseptic and is usually well-tolerated with few side effects. Some people might notice a change in taste or mild mouth irritation.

Overall, both treatments are considered safe for short-term use. This trial phase focuses on evaluating the effectiveness and safety of these treatments for people with oral cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for oral cancer?

Researchers are excited about using metronidazole and chlorhexidine for oral cancer because these agents offer a novel approach by combining antibiotics and antiseptic properties. Unlike traditional treatments that primarily focus on chemotherapy, radiation, or surgery, this combination targets bacterial involvement and aims to reduce infection and inflammation before surgical resection. The potential to improve surgical outcomes by minimizing bacterial interference is what makes this approach particularly promising.

What evidence suggests that this treatment might be an effective treatment for oral cancer?

In this trial, participants will receive a combination of metronidazole and chlorhexidine. Research has shown that metronidazole can harm cancer cells by putting them under stress, aiding in cancer treatment. This stress is the reason metronidazole is being studied as a cancer treatment. Chlorhexidine, the mouthwash used in this study, is known for its antibacterial properties. Together, these treatments aim to reduce harmful bacteria in oral tumors, potentially improving outcomes for oral cancer patients. ^{3 6 7 8 9}

Who Is on the Research Team?

Natalie Silver, MD

Principal Investigator

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2772417424000748

Metronidazole delivery strategies: Optimizing cancer ... Metronidazole's anticancer potential relates to its ability to induce oxidative stress and cause DNA damage in cancer cells, primarily through the generation of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28174164/

Improving malodour management in advanced cancer Outcomes were poor during the period when only topical or intermittent oral metronidazole was used. Topical use gradually decreased (97% vs 55%) and the ...

3. researchgate.net researchgate.net/publication/328845433_The_effect_of_metronidazole_on_the_viability_of_CAl-27_tongue_cancer_cells

The effect of metronidazole on the viability of CAl-27 ... The MTT test revealed a significant increase in cell viability under the influence of metronidazole after 24 h, at the highest concentration of ...

4. bibliotekanauki.pl bibliotekanauki.pl/articles/895561.pdf

THE EFFECT OF METRONIDAZOLE ON THE VIABILITY ... Summarizing, metronidazole stimulates the viability of tongue squamous cell carcinoma cells according to its concentration and the time of incubation (results ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/3339906/

Cancer after exposure to metronidazole - PubMed - NIH The analysis of these data suggests no significant increase in cancer-related morbidity or mortality for women exposed to metronidazole for treatment of ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK590895/

Metronidazole - 15th Report on Carcinogens - NCBI Bookshelf Oral exposure to metronidazole caused tumors at several different tissue sites in mice and rats. Dietary administration of metronidazole caused benign and ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2010/012623s061lbl.pdf

WARNING Metronidazole has been shown to be carcinogenic ... Metronidazole has been shown to be carcinogenic in mice and rats. (See. PRECAUTIONS.) Unnecessary use of the drug should be avoided. Its use should be reserved ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29595104/

Association of Metronidazole with Cancer: A Potential Risk ... MTZ has been reported to induce cancer in a variety of animal models including lung cancer, malignant lymphomas, breast cancer, hepatocellular carcinoma, ...

9. cancernetwork.com cancernetwork.com/view/short-term-metronidazole-not-linked-cancer

Short-Term Metronidazole not Linked to Cancer The all-site incidence of cancer after the first 7 years of follow-up was 652 per 100,000 person-years for metronidazole users, compared with 662 for nonusers.