AHCC® capsules for HPV-positive Head and Neck Cancer
This study is looking at how safe and effective AHCC® capsules are when given along with standard treatments for people with HPV-positive head and neck squamous cell carcinoma (HNSCC). This is a type of cancer that affects the head and neck and is linked to the human papillomavirus (HPV). You may be able to join if you are between 18 and 79 years old, have been diagnosed with HPV-positive HNSCC, and have either had surgery or will be having surgery. The study aims to see how long people live (Overall Survival) when taking AHCC® capsules with their usual treatment, measured over 60 months. The current recruitment status is unclear.
- Study design
- This is a Phase 2, single-arm, open-label study, meaning all 34 participants will receive the study intervention. It will look at the safety and tolerability of AHCC® capsules.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants' overall survival will be measured at 60 months after starting treatment.
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NCT06693323
Single-Center Eval of Clinical & Radiological Benefit AHCC in Combo W/ SOC Tx for HPV+ Pts W/ HNSCC
Recruiting
PHASE2Ages 18–79InterventionalTreatmentUniversity of California, IrvineInvestigator-initiated
~34 participants
Updated 2025-03-27 on ClinicalTrials.gov
What's tested:AHCC®capsules
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS) of Patients receiving AHCC and concurrent standard of care treatment regimens
Measured over 60 months
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Rupali Nabar, MD · PRINCIPAL_INVESTIGATOR · Chao Family Comprehensive Cancer Center
Who to contact
Chao Family Comprehensive Cancer Center University of California, Irvine
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Eligibility criteria
Inclusion
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:
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 member available will also be considered eligible.
All females of childbearing potential must have a blood test or urine study within 14 days prior to registration negative for pregnancy.
Women of childbearing potential and sexually active males must not conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse while on study treatment, and continue for 120 days after the last dose of study treatment. Accepted and effective methods are described in Appendix 4
Has adequate organ and marrow function as defined below, based on clinical laboratory assessments obtained ≤ 28 days prior to registration:
Exclusion
Patient must not be pregnant or breast-feeding due to the unknown potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
Current active infection that requires systemic treatment at time of registration.
History of solid organ transplant or stem cell transplant.
Currently taking immunosuppressive medication within 7 days prior to registration, EXCEPT for the following:
New York Heart Association Class III or IV heart failure. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.
Received a live vaccine within 30 days prior to the first dose of study drug.
Known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as positive for HCV RNA on a qualitative test).
History of HIV with or without antiviral treatment having
Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
Known allergy to mushrooms, mushroom products, or any components of the study formulation.
Known psychiatric or substance abuse disorder that would interfere with the participant's ability to complete study assessments or to adhere to protocol requirements.
What this trial measures
- Overall Survival (OS) of Patients receiving AHCC and concurrent standard of care treatment regimens60 months
To evaluate the overall survival of patients with HPV-positive Head and Heck squamous cell carcinoma