Actively Recruiting
A Phase I/IIa Study Evaluating Oral Nisin Effects and Safety in Oral Cavity Squamous Cell Carcinoma Patients Undergoing Surgical Resection
Led by University of California, San Francisco ยท Updated on 2026-04-13
40
Participants Needed
1
Research Sites
30 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
Researchers are evaluating oral nisin administration in patients with oral cavity squamous cell carcinoma (OSCC) who are having complete surgical removal of their cancer, with or without additional radiation or chemoradiation treatments as part of their usual care. The study aims to find the highest tolerated dose of nisin, assess how feasible it is for patients to complete the treatment, and explore its effects on tumor size, periodontal health, the oral microbiome, immune response, and survival outcomes. Participants will take oral nisin once daily, starting two weeks before their planned surgery and continuing for six months after surgery. The dose in Phase 1 begins at 20,000 mg daily, with adjustments allowed for side effects. During surgery, nisin is temporarily paused. After determining the recommended dose from Phase 1, Phase IIa participants will receive that dose following the same schedule, alongside their standard surgical and adjuvant treatments. During the study, participants will undergo dental exams measuring tumor and ulceration size and periodontal health, and researchers will collect data on side effects and tumor response. They will also study changes in the oral microbiome and immune cells, and monitor survival and relapse rates. Treatment tolerability, completion rates, and safety are primary outcomes. Follow-up continues for 12 months after surgery to assess longer-term effects and safety.
CONDITIONS
Brief Title
Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected clinical diagnosis of oral cavity squamous cell carcinoma (OSCC) planning a diagnostic biopsy
- Histological or cytological confirmation of OSCC before enrollment
- OSCC tumor size 2 cm or larger
- Non-metastatic OSCC (metastasis to neck allowed, no distant metastases)
- Planned complete OSCC surgical resection at UCSF with or without adjuvant radiation/chemoradiation
- Age 18 years or older
- ECOG performance status 0, 1, or 2 (Karnofsky score 50% or higher)
- Dentate with at least two natural teeth
- Ability to understand and sign informed consent
You will not qualify if you...
- History of positive human papillomavirus (HPV) DNA test (P16-positive allowed if HPV DNA negative)
- History or current oropharyngeal, laryngeal, or hypopharyngeal cancers other than OSCC
- Other malignancies interfering with study safety or endpoints
- Ongoing uncorrected oral pathology that could interfere with safety or study outcomes
- Known hypersensitivity or allergy to nisin or related preservatives
- Complete inability to absorb nutrients via the gastrointestinal tract
- Extended antibiotic therapy over 4 weeks within 1 month before baseline or current continuous antibiotic prophylaxis
- Requirement for systemic anticancer therapy before enrollment, except prior or concurrent immunotherapy
- Use of other investigational anticancer agents or devices, except immunotherapy
- Ongoing unstable Grade 2 or higher adverse events
- Conditions or social situations impairing ability to comply with study or safety
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months post-surgery plus 2 weeks pre-surgery
Participants take oral nisin once daily starting two weeks before planned surgical removal of the oral cavity tumor. Nisin is paused during surgery and resumed after recovery, continuing daily for 6 months post-surgery, including during any adjuvant radiation or chemoradiation treatment if applicable.
1 baseline visit before treatment, weekly visits during treatment and post-surgery period
Duration - Surgery day and immediate inpatient care period
Participants undergo complete surgical resection of the oral cavity squamous cell carcinoma as part of standard care. Nisin treatment is temporarily withheld during the inpatient surgical period.
1 surgery visit (inpatient)
Duration - Up to 12 months post-surgery
Participants are followed for safety, tumor response, periodontal condition, and survival outcomes for up to 12 months after surgery and treatment completion.
Monthly visits for up to 12 months post-treatment
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
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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