RECRUITING

Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC)

Conditions

Oral Cavity Squamous Cell Carcinoma Oral Microbiome Natural Food Preservative

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase I/IIa, Single-Arm, Dose-Confirmation and Dose-Expansion Study Evaluating Changes in the Oral Microbiome of Patients With Oral Cavity Squamous Cell Carcinoma (OSCC) After Short-Term Ingestion of Nisin, a Naturally Occurring Food Preservative

Quick Facts

Study Start:2024-02-02

Study Completion:2027-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06097468

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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. Concurrent systemic anticancer therapy or chemoradiation is permitted after enrollment. 8. Individuals currently receiving any other investigational agent or using an investigational device intended as anticancer therapy. 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.

Inclusion Criteria

Exclusion 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.

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. Concurrent systemic anticancer therapy or chemoradiation is permitted after enrollment.
8. Individuals currently receiving any other investigational agent or using an investigational device intended as anticancer therapy.
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.

Contacts and Locations

Study Contact

Angelica Valadez

CONTACT

415-502-1879

Angelica.Valadez@ucsf.edu

Principal Investigator

Sue Yom, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Yvonne Kapila, MD

PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Sue Yom, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
Yvonne Kapila, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-02

Study Completion Date2027-09-01

Study Record Updates

Study Start Date2024-02-02

Study Completion Date2027-09-01

Terms related to this study

Keywords Provided by Researchers

Oral Microbiome
Natural Food Preservative

Additional Relevant MeSH Terms

Oral Cavity Squamous Cell Carcinoma