Back to search results

Nisin for Oral Cavity Squamous Cell Carcinoma

This study is testing NisinZ® P, a natural substance derived from sauerkraut, in people with oral cavity squamous cell carcinoma (OCSCC), a type of mouth cancer. The goal is to see how well NisinZ® P is tolerated and if it's practical to give to patients. You may be able to join if you are 18 or older, have a suspected or confirmed diagnosis of OCSCC, and are planning to have surgery. The study will look at how many participants experience side effects (toxicities) and how many complete the treatment. Researchers will also measure tumor size changes and check for any impact on your oral health. The study aims to enroll 40 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 40 participants.
What's involved
You would receive NisinZ® P and undergo surgery as part of your standard care. The study will assess side effects for up to 6 months and treatment completion for up to 6 months.
Compensation
Not stated in the trial record.
Follow-up
The study will assess side effects and treatment completion for up to 6 months. Relapse-free survival and overall survival will also be evaluated.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06097468

Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC)

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of California, San Francisco
~40 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:NisinZ® PSurgery (non-interventional, standard of care)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with dose limiting toxicities (DLT) (Phase I)
Measured over Up to 6 months
+2 more outcomes measured

Conditions

Oral Cavity Squamous Cell Carcinoma

Explore related trials

Oral Cavity Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Sue Yom, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
  • Yvonne Kapila, MD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles

Who to contact

Narimane Badawi
[email protected]
(415) 866-7594
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Exclusion

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.

What this trial measures

  • Proportion of participants with dose limiting toxicities (DLT) (Phase I)Up to 6 months

    Dose-limiting toxicities (DLTs) are defined in Section 5.2.3. DLT determination will assess adverse events (AEs) graded according to CTCAE v5.0, including findings on physical exam, vital signs, laboratory testing, and spontaneous reports of AEs reported to the investigator by participants. DLT data will be summarized as proportions of participants experiencing DLTs per cohort

  • Maximum Tolerated Dose / Recommended Phase II Dose (RP2D) (Phase I)Up to 4 weeks

    The maximum tolerated dose (MTD) is the highest dose at which no more than one instance of DLT is observed among 6 participants treated. The MTD from Phase I will be the recommended Phase IIa dose (RP2D) for use in Phase IIa.

  • Proportion of participants completing treatment (Phase II)Up to 6 months

    The treatment completion rate is defined as the proportion of participants allocated to receive nisin at the RP2D and who complete the full nisin regimen, missing fewer than 30% of doses over the course of the regimen. A full nisin regimen is defined as starting nisin 2 weeks before surgery and continuing for 6 months after surgery.