Single-Center Eval of Clinical & Radiological Benefit AHCC in Combo W/ SOC Tx for HPV+ Pts W/ HNSCC
This study tests whether a supplement called AHCC, when combined with standard cancer treatment, is safe and helpful for people with HPV-positive head and neck cancer who have had or will have surgery. Researchers will evaluate how well the body tolerates AHCC and whether it provides any additional clinical or imaging benefits alongside regular treatment.
Key Objective:This trial is testing whether AHCC combined with standard treatment can improve clinical outcomes and be safely tolerated in HPV-positive head and neck cancer patients.
Who to Consider:Patients with HPV-positive head and neck squamous cell carcinoma who have undergone or are planning to undergo surgery should consider enrolling.
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a phase 2, single-arm, open-label clinical trial determining safety and tolerability of AHCC in subjects with HPV-positive patients with Head and Neck Squamous Cell Carcinoma. These are subjects who have undergone surgery or will be undergoing surgery.
Eligibility Criteria
Inclusion Criteria: * Between 18 and 79 years of age. * Has a diagnosis of pathologically or cytologically proven HPV positive HNSCC. * For patients who have undergone surgery, they must be registered at least 4 weeks after surgery. * For patients that have completed surgery, has a high risk disease defined as: 1. Positive Margins and/or Extra Nodal Extension (ENE) 2. Positive margins are defined as malignancy at or within 1 mm of the margin. High grade dysplasia (i.e., carcinoma in situ) at the margin is also considered positive 3. ENE may be either gross or microscopic * No evidence of distant disease based on baseline imaging done within 28 days prior to registration. Patient may be any T or N stage, but must be M0 * Has an ECOG Performance Status 0-1. * Has the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family memb