Study on Nisin for Treating Oral Cavity Squamous Cell Carcinoma (OCSCC)

Sponsor: University of California, San Francisco

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06097468

Provider View

This clinical trial is testing the use of nisin, a natural preservative, in patients with oral cavity squamous cell carcinoma (OSCC) who are undergoing surgery at the University of California, San Francisco (UCSF).

Patient Parameters

Program Overview

The study aims to find out if nisin, a natural preservative, can be safely used in patients with oral cavity squamous cell carcinoma (OSCC) who are having surgery to remove their cancer. Researchers want to see if nisin is safe and if it can help improve treatment outcomes when given before and after surgery. Participants will receive nisin for two weeks before their surgery and continue for six months after. The study will follow up with participants for a year after surgery to monitor their health and any changes in their cancer.

Description

The main goals of this study are to determine if nisin is safe and well-tolerated in patients with oral cavity squamous cell carcinoma (OSCC) and to see if patients can complete the treatment as planned. Researchers will also look at any side effects and how nisin affects the size of the cancer and the health of the gums and teeth.

Additionally, the study will explore how nisin changes the bacteria in the mouth and how it affects the body's immune response to cancer. Researchers will also study how nisin is processed in the body and its potential effectiveness in preventing cancer from returning.

Participants will start in Phase 1 to find the best dose of nisin. After this, Phase IIa will begin, where participants will receive the determined dose. Treatment will last for two weeks before surgery and continue for six months after. Follow-up will last for 12 months post-surgery to monitor health and cancer status.

Eligibility Criteria

Inclusion Criteria

  • Have a suspected diagnosis of oral cavity squamous cell carcinoma (OSCC) and plan to have a biopsy to confirm it.
  • The OSCC tumor must be 2 cm or larger.
  • The cancer must not have spread to distant parts of the body, but can have spread to the neck.
  • Plan to have surgery to remove the OSCC at UCSF, with or without additional radiation or chemoradiation.
  • Be 18 years or older.
  • Have a performance status score of 0, 1, or 2, indicating good overall health.
  • Have at least two teeth for collecting plaque samples.
  • Be able to understand and willing to sign a consent form to participate.

Exclusion Criteria

  • Have a positive test for human papillomavirus (HPV) DNA, unless P16-positive and HPV DNA negative.
  • Have a history of or current cancers in the oropharynx, larynx, or hypopharynx, except OSCC.
  • Have untreated oral health issues that could interfere with the study or worsen during participation.
  • Have allergies to nisin or related preservatives.
  • Have a medical condition that prevents nutrient absorption through the digestive system.
  • Have taken antibiotics for more than four weeks within a month before starting the study or need continuous antibiotics.
  • Need systemic anticancer therapy before starting the study.
  • Are currently using other investigational cancer treatments.
  • Have ongoing severe health issues that are not stable.
  • Have any condition or situation that could affect the ability to participate safely in the study.

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