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RECRUITING
NCT06097468
PHASE1/PHASE2

Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC)

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-02-02

Completion Date

2027-09-01

Last Updated

2025-07-10

Healthy Volunteers

No

Interventions

DRUG

NisinZ® P

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

PROCEDURE

Surgery (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