RecruitingPhase 1Phase 2NCT06097468

Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC)

A Phase I/IIa, Single-Arm, Dose-Confirmation and Dose-Expansion Study Evaluating Changes in the Oral Microbiome of Patients With Oral Cavity Squamous Cell Carcinoma (OSCC) After Short-Term Ingestion of Nisin, a Naturally Occurring Food Preservative

Sponsor

University of California, San Francisco

Enrollment

40 participants

Start Date

Feb 2, 2024

Study Type

INTERVENTIONAL

Conditions

Oral Cavity Squamous Cell Carcinoma

Summary

This is a study of oral nisin administration in patients with OSCC who are undergoing complete surgical resection surgery with or without adjuvant radiation/chemoradiation as part of their routine care at the University of California, San Francisco (UCSF).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether nisin — a natural antimicrobial substance found in some dairy foods — can affect oral cavity squamous cell carcinoma (mouth cancer). It is being given as a mouth rinse before surgery to see if it changes the cancer's biology and the bacteria living in the mouth. **You may be eligible if...** - You are 18 years or older - You have a suspected or confirmed diagnosis of oral cavity squamous cell carcinoma (mouth cancer) confirmed by biopsy - Your tumor is at least 2 cm in size - Your cancer has NOT spread to distant organs (spread to neck lymph nodes is allowed) - You are planning to have surgical removal of your mouth cancer at UCSF - You still have at least two teeth (needed for the study's saliva/plaque samples) - You are in reasonable health (able to perform daily activities) **You may NOT be eligible if...** - You have a known HPV-positive oral cancer - You have already had prior radiation or chemotherapy for this cancer - You are allergic to nisin or dairy-based products Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNisinZ® P

NisinZ® P is an ultrapure Nisin Z concentrate produced by fermentation using the bacterium Lactococcus lactis obtained from sauerkraut

PROCEDURESurgery (non-interventional, standard of care)

Surgical removal of tumor as part of standard of care treatment

Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT06097468

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