Actively Recruiting
Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC)
Led by University of California, San Francisco · Updated on 2026-04-13
40
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
U
University of California, Los Angeles
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with suspected clinical diagnosis of oral cavity squamous cell carcinoma (OSCC) planning a diagnostic biopsy, with confirmed OSCC by biopsy pathology report before enrollment
- OSCC tumor size must be at least 2 cm
- Non-metastatic OSCC (no distant metastases; neck metastasis allowed)
- Planning complete surgical resection of OSCC with or without adjuvant radiation/chemoradiation at UCSF as routine care
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Karnofsky score ≥ 50%)
- Must have at least two natural teeth (dentate) for plaque sample collection
- Ability to understand and sign informed consent
You will not qualify if you...
- History of positive human papillomavirus DNA test (P16-positive allowed if HPV DNA negative)
- History or current oropharyngeal, laryngeal, or hypopharyngeal cancers other than OSCC
- Other prior or concurrent cancers that could interfere with safety or study endpoints
- Ongoing untreated oral pathology that could interfere with safety or study, including major dental surgery needs, untreated cavities, severe infections, or defective restorations
- Known allergy or hypersensitivity to nisin or related food preservatives
- Complete inability to absorb nutrients via gastrointestinal tract due to major disorder or surgery
- Extended antibiotic therapy (>4 weeks) within 1 month before baseline or need for continuous antibiotic prophylaxis
- Need for systemic anticancer therapy before enrollment (except prior immunotherapy)
- Current use of other investigational anticancer agents or devices (except immunotherapy)
- Ongoing unstable Grade 2 or ≥ Grade 3 adverse events
- Any condition or social situation that could impair safety, compliance, or study outcomes
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
N
Narimane Badawi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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