Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC)

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Oct 18, 2023

Keywords

ClinConnect Summary

The clinical trial titled "Nisin in Oral Cavity Squamous Cell Carcinoma" is studying the effects of a substance called nisin when taken by mouth in patients who have been diagnosed with a type of cancer in the mouth called oral cavity squamous cell carcinoma (OSCC). This trial is taking place at the University of California, San Francisco (UCSF) and is open to patients who are planning to have surgery to remove their cancer, with or without additional treatments like radiation. The goal is to see if nisin can help improve outcomes for these patients.

To participate in this trial, individuals need to be at least 18 years old, have a confirmed diagnosis of OSCC that is at least 2 centimeters in size, and be scheduled for surgery at UCSF. Participants should also have at least two teeth, as samples will be collected for research. Those who have certain other health issues or treatments that might interfere with the study may not be eligible. If you join the study, you will continue to receive the usual care for your cancer while also taking nisin as part of the research. This trial is currently recruiting participants, so if you or someone you know is interested, it may be worth discussing with a healthcare provider.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants with a suspected clinical diagnosis of oral cavity squamous cell carcinoma (OSCC) who are planning to undergo a diagnostic biopsy. Note: Subsequent documentation from the medical record (e.g., from the diagnostic biopsy pathology report) of histological or cytological confirmation of OSCC is required prior to enrollment and treatment on study. Participants who do not have a histological/cytological confirmation of OSCC, or who are unable to provide sufficient volume of biopsy tissue for research, will not be eligible to enroll in the study.
• • 2. OSCC mass must be \>= 2cm in size.
• • 3. Non-metastatic OSCC (no distant metastases allowed; metastasis to the neck is eligible).
• • 4. Participants must be planning for a complete OSCC surgical resection, with or without adjuvant radiation/chemoradiation, at UCSF, as part of their routine treatment plan. Surgical resection and adjuvant treatment will be according to the participants routine or standard of care treatment plan and will not be dictated by the study (non-interventional).
• • 5. Age \>= 18 years
• • 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky ≥ 50%).
• • 7. Participants must be dentate (retaining at least two teeth). Teeth are required for plaque sample collection for correlative studies.
• • 8. Ability to understand and willingness to sign a written informed consent document.
• Exclusion Criteria:
• • 1. Individuals with a history of a known positive human papillomavirus deoxyribonucleic acid ((HPV DNA) test (P16-positive is permitted if HPV DNA test is negative).
• • 2. Individuals with a history of or concurrent oropharyngeal, laryngeal, or hypopharyngeal cancers (other than OSCC). Individuals with any other prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.
• • 3. Individuals with ongoing uncorrected oral pathology, which in the opinion of the investigator could interfere with the safety or endpoints of this study or could be exacerbated during the course of study participation, if left untreated. These conditions may be discussed with the study PI to determine eligibility.
• • Current and ongoing long-term dental treatment requiring major surgery;
• • Untreated carious lesions, severe oral infections, or known defective restorations;
• • Other suspicious uncorrected oral pathology.
• • 4. Individuals with a known history of hypersensitivity reactions or oral allergies to nisin, any of its excipients, or any related food preservatives.
• • 5. Individuals with complete inability to absorb nutrients via gastrointestinal tract due to major medical disorder or history of gastrointestinal surgical removal.
• • 6. Individuals who have received extended (\>4 weeks) antibiotic therapy within 1 month of the baseline visit or who currently require continuous antibiotic prophylaxis at the time of enrollment.
• • 7. Individuals who require treatment with a systemic anticancer therapy prior to enrollment, with the exception of prior immunotherapy which is permitted both prior to enrollment and concurrent with study participation.
• • 8. Individuals currently receiving any other investigational agent or using an investigational device intended as anticancer therapy, with the exception of investigational immunotherapy, which is permitted both prior to enrollment and concurrent with study participation.
• • 9. Individuals with ongoing Grade 2 events that are not clinically stable or ongoing \>= Grade 3 events (CTCAE v5.0 grading).
• • 10. Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study activities, interfere with participant safety, or study endpoints.