RecruitingPhase 2NCT06693323

Single-Center Eval of Clinical & Radiological Benefit AHCC in Combo W/ SOC Tx for HPV+ Pts W/ HNSCC

Single-Center Evaluation of the Clinical and Radiological Benefit of AHCC® in Combination with Standard of Care Treatment for HPV-Positive Patients with Head and Neck Squamous Cell Carcinoma (HNSCC)


Sponsor

University of California, Irvine

Enrollment

34 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether adding AHCC — a natural mushroom extract supplement — to standard cancer treatment helps patients with HPV-positive head and neck cancer (such as throat or tonsil cancer). Researchers are looking at whether it improves treatment outcomes and quality of life. **You may be eligible if...** - You are between 18 and 79 years old - You have been diagnosed with HPV-positive head and neck squamous cell cancer (confirmed by biopsy or tissue analysis) - If you have had surgery, you must be enrolled at least 4 weeks after the procedure - After surgery, your cancer shows high-risk features such as positive surgical margins or cancer spreading beyond the lymph nodes - Your cancer has not spread to distant organs (you are M0 stage) - You are in good functional health (ECOG performance status 0–1) **You may NOT be eligible if...** - You are unwilling or unable to give informed consent - You are pregnant (a negative pregnancy test is required) - You have evidence of cancer spread beyond the head and neck area Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAHCC®capsules

Given PO


Locations(1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States

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NCT06693323


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