Could a food preservative help fight oral cancer?
NCT ID NCT06097468
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether nisin, a natural preservative found in some foods, can safely change the bacteria in the mouths of people with oral cavity squamous cell carcinoma. About 40 patients will take nisin before and after their standard surgery. The goal is to find a safe dose and see if it affects the mouth's microbiome.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nisin (a natural food preservative)
- What this could lead to
- If it works, this could point toward a simple, low-cost way to improve outcomes for oral cancer patients by altering mouth bacteria.
- What could go wrong
- This is a very early, small trial (40 people) testing safety and dosing. It may not show any benefit, and nisin might cause side effects or fail to change bacteria meaningfully.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants with a suspected clinical diagnosis of oral cavity squamous cell carcinoma (OSCC) who are planning to undergo a diagnostic biopsy. Note: Subsequent documentation from the medical record (e.g., from the diagnostic biopsy pathology report) of histological or cytological confirmation of OSCC is required prior to enrollment and treatment on study. Participants who do not have a histological/cytological confirmation of OSCC, or who are unable to provide sufficient volume of biopsy tissue for research, will not be eligible to enroll in the study. 2. OSCC mass must be \>= 2cm in size. 3. Non-metastatic OSCC (no distant metastases allowed; metastasis to the neck is eligible). 4. Participants must be planning for a complete OSCC surgical resection, with or without adjuvant radiation/chemoradiation, at UCSF, as part of their routine treatment plan. Surgical resection and adjuvant treatment will be according to the participants routine or standard of care treatment plan and will not be dictated by the study (non-interventional). 5. Age \>= 18 years 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky ≥ 50%). 7. Participants must be dentate (retaining at least two teeth). Teeth are required for plaque sample collection for correlative studies. 8. Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: 1. Individuals with a history of a known positive human papillomavirus deoxyribonucleic acid ((HPV DNA) test (P16-positive is permitted if HPV DNA test is negative). 2. Individuals with a history of or concurrent oropharyngeal, laryngeal, or hypopharyngeal cancers (other than OSCC). Individuals with any other prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible. 3. Individuals with ongoing uncorrected oral pathology, which in the opinion of the investigator could interfere with the safety or endpoints of this study or could be exacerbated during the course of study participation, if left untreated. These conditions may be discussed with the study PI to determine eligibility. * Current and ongoing long-term dental treatment requiring major surgery; * Untreated carious lesions, severe oral infections, or known defective restorations; * Other suspicious uncorrected oral pathology. 4. Individuals with a known history of hypersensitivity reactions or oral allergies to nisin, any of its excipients, or any related food preservatives. 5. Individuals with complete inability to absorb nutrients via gastrointestinal tract due to major medical disorder or history of gastrointestinal surgical removal. 6. Individuals who have received extended (\>4 weeks) antibiotic therapy within 1 month of the baseline visit or who currently require continuous antibiotic prophylaxis at the time of enrollment. 7. Individuals who require treatment with a systemic anticancer therapy prior to enrollment, with the exception of prior immunotherapy which is permitted both prior to enrollment and concurrent with study participation. 8. Individuals currently receiving any other investigational agent or using an investigational device intended as anticancer therapy, with the exception of investigational immunotherapy, which is permitted both prior to enrollment and concurrent with study participation. 9. Individuals with ongoing Grade 2 events that are not clinically stable or ongoing \>= Grade 3 events (CTCAE v5.0 grading). 10. Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study activities, interfere with participant safety, or study endpoints.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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University of California, San Francisco
RECRUITINGSan Francisco, California, 94143, United States
Contact Email: •••••@•••••
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