Study on AHCC and Standard Treatment for HPV-Positive Head and Neck Cancer Patients

Sponsor: University of California, Irvine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06693323

Provider View

This clinical trial is testing the safety and tolerability of AHCC, a natural compound, in combination with standard treatment for patients with HPV-positive head and neck cancer who have had or will have surgery.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and tolerability of AHCC, a natural compound, in patients with HPV-positive head and neck squamous cell carcinoma (HNSCC). The study is open to patients who have already undergone surgery or are planning to have surgery for their cancer.

Eligibility Criteria

Inclusion Criteria

  • Aged between 18 and 79 years.
  • Diagnosed with HPV-positive head and neck squamous cell carcinoma (HNSCC).
  • If surgery has been completed, patients must be registered at least 4 weeks after surgery.
  • For those who have completed surgery, the cancer must be considered high risk, which includes:
    • Cancer cells found at the edge of the removed tissue or cancer spread beyond the lymph nodes.
  • No signs of cancer spread to distant parts of the body based on recent imaging.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Ability to understand and sign a consent form. Patients with decision-making difficulties can participate if they have a legal representative or caregiver.
  • Women of childbearing potential must have a negative pregnancy test within 14 days before joining the study.
  • Women and sexually active men must use effective birth control during the study and for 120 days after the last treatment dose.
  • Must have adequate organ and bone marrow function, as shown by specific blood test results:
    • Neutrophil count of at least 1,500/μL
    • Platelet count of at least 100,000/μL
    • Total bilirubin within 1.5 times the normal limit
    • AST/ALT within 3 times the normal limit
    • Creatinine clearance greater than 30 mL/min

Exclusion Criteria

  • Must not be pregnant or breastfeeding due to potential risks to the baby.
  • Have an active infection requiring treatment at the time of joining the study.
  • Have a history of organ or stem cell transplant.
  • Currently taking immunosuppressive medication, except for certain types like:
    • Nasal, inhaled, or topical steroids
    • Low-dose systemic steroids
    • Steroids for allergic reactions
  • Have severe heart failure (Class III or IV) or significant heart disease.
  • Have received a live vaccine within 30 days before starting the study.
  • Have a history of Hepatitis B or active Hepatitis C.
  • Have HIV with detectable viral loads or certain related conditions.
  • Have an active autoimmune disease requiring treatment in the past 2 years.
  • Have an allergy to mushrooms or any study components.
  • Have a psychiatric or substance abuse disorder that would interfere with study participation.

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