Phase 2 Head and Neck Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are suspected to have a type of mouth cancer called oral cavity squamous cell carcinoma (OSCC), and who are planning to have a diagnostic biopsy to confirm the diagnosis — confirmation of cancer from that biopsy is required before a person can formally enrol.
• People whose mouth cancer tumour is at least 2 centimetres in size.
• People whose cancer has not spread to distant parts of the body (spread to the neck lymph nodes is acceptable).
• People who are already planning to have their mouth cancer completely removed by surgery at UCSF, with or without follow-up radiation or chemotherapy, as part of their normal care plan.
• People aged 18 years or older.
• People who are well enough to carry out basic daily activities, as measured by a standard health scale (ECOG score of 0, 1, or 2, or Karnofsky score of 50% or above) (confirm with trial site if unsure what this means).
• People who still have at least two natural teeth, as tooth plaque samples are needed for research purposes.
• People who are able to understand and willing to sign a written consent form.

Who may not be able to join:

• People who have previously had a positive HPV DNA test result (a positive p16 result alone, without a positive HPV DNA test, may still be eligible — confirm with trial site).
• People who have a history of, or currently have, cancers of the throat, voice box, or related areas (other than mouth cancer); however, people with other past or current cancers that are unlikely to interfere with the study may still be considered eligible (confirm with trial site).
• People who have untreated or ongoing mouth or dental problems that, in the opinion of the study doctor, could interfere with the study or get worse during participation — this includes ongoing major dental surgery, untreated tooth decay, serious mouth infections, known faulty dental restorations, or other unexplained mouth concerns (confirm with trial site, as some cases may be reviewed individually).
• People who have a known allergy or sensitivity to nisin (a natural food preservative), any of its ingredients, or related food preservatives.
• People who are completely unable to absorb nutrients through their digestive system due to a serious medical condition or because of surgical removal of part of the digestive tract.
• People who have taken antibiotics for more than 4 weeks within the month before their first study visit, or who currently need to take antibiotics continuously.
• People who need to receive systemic anti-cancer treatment (such as chemotherapy) before enrolling in the study — prior or ongoing immunotherapy is an exception and is permitted.
• People who are currently taking part in another clinical trial using an experimental anti-cancer treatment or device — participation in investigational immunotherapy is an exception and is permitted.
• People who are currently experiencing certain moderate-to-severe or unstable side effects or health events, as graded by a standard medical scale (CTCAE v5.0) (confirm with trial site for details).
• People who have any condition or personal circumstance that, in the opinion of the study doctor, would make it difficult to take part safely or complete study activities.

Important: Always verify eligibility with the trial site directly before applying.