Study of Oral Nisin Treatment in Adults Undergoing Surgery for Oral Cavity Squamous Cell Carcinoma

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.

Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC)