AHCC Capsules for Head and Neck Cancer

Overseen By University of California Irvine Medical

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Irvine

Must not be taking: Immunosuppressants, Live vaccines

Disqualifiers: Pregnancy, Infection, Transplant history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 cycles (each cycle is 28 days)

34 Participants Needed

Trial Summary

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on immunosuppressive medication within 7 days before joining, except for certain low-dose steroids and specific premedications.

How is the AHCC treatment different from other treatments for head and neck cancer?

AHCC (Active Hexose Correlated Compound) is unique because it is a natural supplement derived from mushrooms, which may support the immune system, unlike traditional chemotherapy drugs that directly target cancer cells. This makes it a novel approach as it potentially enhances the body's natural defenses rather than directly attacking the cancer. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Rupali Nabar

Principal Investigator

Chao Family Comprehensive Cancer Center

Eligibility Criteria

Adults aged 18-79 with HPV-positive Head and Neck Squamous Cell Carcinoma (HNSCC) who've had or will have surgery. They must be at high risk for disease recurrence, not pregnant, willing to use contraception, and free from serious infections, autoimmune diseases treated within the last 2 years, organ transplants, certain heart conditions, HIV with detectable viral load or history of specific diseases.

Inclusion Criteria

I had surgery at least 4 weeks ago.

For patients that have completed surgery, has a high risk disease defined as: Positive Margins and/or Extra Nodal Extension (ENE), No evidence of distant disease based on baseline imaging done within 28 days prior to registration, Has an ECOG Performance Status 0-1, Has the ability to understand and the willingness to sign a written informed consent document, 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, Has adequate organ and marrow function as defined below, based on clinical laboratory assessments obtained ≤ 28 days prior to registration

My throat cancer is caused by HPV.

Exclusion Criteria

I am not currently being treated for an infection.

Known psychiatric or substance abuse disorder that would interfere with the participant's ability to complete study assessments or to adhere to protocol requirements

I have not taken immunosuppressive medication in the last 7 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AHCC in combination with standard of care treatment for HPV-positive Head and Neck Squamous Cell Carcinoma

24 cycles (each cycle is 28 days)

Follow-up

Participants are monitored for safety, tolerability, and changes in HPV DNA as a marker of tumor response or recurrence

5 years

Treatment Details

Interventions

• AHCC

Trial Overview The trial is testing AHCC® capsules' safety and tolerability in HPV-positive HNSCC patients post-surgery. It's a phase 2 study where all participants receive the same treatment without a comparison group.

Participant Groups

Group I: AHCC Experimental Treatment 1 Intervention

Oral Drug

AHCC is already approved in Japan, United States for the following indications:

Approved in Japan as AHCC for:

• General health maintenance
• Immune support
• Complementary therapy for cancer patients

Approved in United States as AHCC for:

• Dietary supplement for immune support
• Complementary therapy for cancer patients

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Findings from Research

Paclitaxel was found to be more effective than carboplatin in inducing cell death (apoptosis) and inhibiting growth of head and neck squamous cell carcinoma (HNSCC) cells, with its action linked to increased cyclin B1/CDC2 activity and prolonged mitotic arrest.

Combining paclitaxel and carboplatin, either simultaneously or sequentially, resulted in greater inhibition of cell growth compared to using either drug alone, highlighting the potential for enhanced therapeutic strategies in treating HNSCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of cell-cycle checkpoint pathways in head and neck cancer cell lines: implications for therapeutic strategies. Coleman, SC., Stewart, ZA., Day, TA., et al.[2019]

Higher T and N stages in head and neck cancer are associated with lower rates of complete local control and survival, highlighting the need for improved treatment strategies.

Combined-modality treatments, such as induction chemotherapy followed by radiotherapy, show promise in enhancing survival and preserving organ function compared to aggressive surgery or radiotherapy alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined modalities in the treatment of head and neck cancers. Aisner, J., Hiponia, D., Conley, B., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Analysis of cell-cycle checkpoint pathways in head and neck cancer cell lines: implications for therapeutic strategies. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Honokiol inhibits epidermal growth factor receptor signaling and enhances the antitumor effects of epidermal growth factor receptor inhibitors. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Honokiol inhibits the growth of head and neck squamous cell carcinoma by targeting epidermal growth factor receptor. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Licochalcone-A induces intrinsic and extrinsic apoptosis via ERK1/2 and p38 phosphorylation-mediated TRAIL expression in head and neck squamous carcinoma FaDu cells. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Combined modalities in the treatment of head and neck cancers. [2015]