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NisinZ® P for Oral Cancer

Phase 1 & 2

Recruiting

Led By Sue Yom, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years

Histological or cytological confirmation of oral cavity squamous cell carcinoma (OSCC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 months

Awards & highlights

Study Summary

This trial tests if taking nisin orally helps reduce cancer recurrence in people having surgery and/or radiation for oral cancer.

Who is the study for?

This trial is for adults with non-metastatic oral cavity squamous cell carcinoma (OSCC) who are undergoing surgery at UCSF. Participants must have confirmed OSCC, be able to consent, and not have distant metastases or a history of certain other cancers. They should not have untreated major dental issues or allergies to nisin.Check my eligibility

What is being tested?

The study tests the effects of an oral compound called NisinZ® P in patients with OSCC alongside their standard surgical treatment. It aims to see if NisinZ® P can improve outcomes when used as part of routine care that may include radiation/chemoradiation post-surgery.See study design

What are the potential side effects?

Potential side effects are not detailed here but could include reactions related to known allergies to nisin or its components, and complications from underlying dental conditions exacerbated by treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer is confirmed as squamous cell carcinoma in the mouth.

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I am scheduled for oral cancer surgery at UCSF, possibly followed by additional treatments.

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I have at least two of my own teeth.

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I can take care of myself but may not be able to do heavy physical work.

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My oral cancer has not spread to distant parts of my body, but may be in my neck.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose / Recommended Phase II Dose (RP2D) (Phase I)

Proportion of participants completing treatment (Phase II)

Proportion of participants with dose limiting toxicities (DLT) (Phase I)

Secondary outcome measures

Incidence of Treatment-emergent adverse events (AE)

Mean change in dimensional measurement of ulcerations over time

Proportion of participants with changes in periodontal bleeding

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase IIa, Dose Expansion (MTD/RP2D)Experimental Treatment2 Interventions

Participants will ingest oral nisin once daily starting two weeks before planned complete OSCC resection surgery and will continue once daily administration for 6 additional months post-surgery (concurrent with adjuvant radiation/chemoradiation, for participants whose routine treatment plan includes adjuvant therapy). Nisin will be temporarily withheld at the time of OSCC resection surgery while the participant is under inpatient care. The dose level will be determined by the outcomes in Phase 1 (RP2D), with dose modification permitted for toxicity management or intolerability.

Group II: Phase I, Dose Finding - Starting Dose (20,000 mg)Experimental Treatment2 Interventions

Participants will ingest oral nisin once daily starting two weeks before planned complete OSCC resection surgery and will continue once daily administration for 6 additional months post-surgery (concurrent with adjuvant radiation/chemoradiation, for participants whose routine treatment plan includes adjuvant therapy). Nisin will be temporarily withheld at the time of OSCC resection surgery while the participant is under inpatient care. The starting dose level, with dose modification permitted for toxicity management or intolerability will be 20,000 mg (2 x 10 g bottles) per day.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,506 Previous Clinical Trials

15,238,515 Total Patients Enrolled

University of California, Los AngelesOTHER

1,532 Previous Clinical Trials

10,265,228 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,669 Previous Clinical Trials

40,926,361 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for participation in this scientific trial?

"Clinicaltrials.gov information reveals that this medical study is no longer accepting participants; it was originally posted on January 1st 2024 and last edited October 18th 2023. Despite this, there are 2794 other clinical trials currently registering patients at the time of writing."

Answered by AI

How does this research endeavor seek to benefit patients?

"The primary goal of this trial, which will run for a maximum of 6 months, is to identify the Maximum Tolerated Dose / Recommended Phase II Dose (RP2D) (Phase I). Secondary objectives include quantifying mean changes in dimensional measurements over time with calipers during dental exams, evaluating proportionality of patients experiencing periodontal pocket depth shifts based on American Academy of Periodontology grading system and measuring clinical detachment loss according to the same criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC)

2024. "Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06097468.