Antibiotics and Mouthwash for Oral Cancer
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.12345Why 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.36789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive metronidazole and chlorhexidine rinses for 10 days prior to surgery
Surgery
Surgical resection of oral cancer is performed
Follow-up
Participants are monitored for changes in intratumoral bacteria and immune cell infiltration
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?
1
Treatment groups
Experimental Treatment
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:
- Pelvic inflammatory disease
- Endocarditis
- Bacterial vaginosis
- Dracunculiasis
- Giardiasis
- Trichomoniasis
- Amebiasis
- Clostridioides difficile colitis
- Pelvic inflammatory disease
- Endocarditis
- Bacterial vaginosis
- Dracunculiasis
- Giardiasis
- Trichomoniasis
- Amebiasis
- Clostridioides difficile colitis
- Pelvic inflammatory disease
- Endocarditis
- Bacterial vaginosis
- Dracunculiasis
- Giardiasis
- Trichomoniasis
- Amebiasis
- Clostridioides difficile colitis
- Pelvic inflammatory disease
- Endocarditis
- Bacterial vaginosis
- Dracunculiasis
- Giardiasis
- Trichomoniasis
- Amebiasis
- Clostridioides difficile colitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Comprehensive Cancer Center
Lead Sponsor
Citations
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 ...
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_cellsThe 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 ...
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 ...
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 ...
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 ...
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 ...
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, ...
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.
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