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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of AHCC (Active Hexose Correlated Compound), a natural compound, for treating head and neck cancer linked to HPV, a common virus. It focuses on patients who have had surgery or are about to undergo surgery for their cancer. Suitable candidates for this trial include those with HPV-positive head and neck cancer who have recently had surgery and are at high risk due to specific surgical findings. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that AHCC is likely to be safe for humans?

Research has shown that AHCC, a supplement made from mushrooms, is generally safe for most people. Studies have found it to be well-tolerated with few side effects. Some individuals might experience mild issues like diarrhea or an upset stomach, but these are uncommon. It is important to note that AHCC has not been proven safe for children, pregnant individuals, or those who are nursing, so these groups should consult a healthcare provider. As this is a phase 2 trial, AHCC has passed initial safety testing and is considered safe for further study in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for head and neck cancer?

Unlike the standard treatments for head and neck cancer, which typically involve surgery, radiation, and chemotherapy, AHCC (Active Hexose Correlated Compound) is a natural compound derived from medicinal mushrooms. Researchers are excited about AHCC because it works by enhancing the immune system, potentially offering a less invasive option with fewer side effects. This immune-boosting approach is different from traditional therapies that directly target and destroy cancer cells, providing a novel pathway that might improve patients' quality of life while combating cancer.

What evidence suggests that AHCC might be an effective treatment for head and neck cancer?

Research has shown that Active Hexose Correlated Compound (AHCC), which participants in this trial will receive, can strengthen the immune system, crucial for fighting cancer. Studies have found that AHCC increases the number of immune cells, such as CD4+ and CD8+, which attack cancer cells. It has been used as a supplement for various health issues, including cancer, to enhance the body's natural defenses. Derived from fungi similar to mushrooms, AHCC is taken to help the body respond better to cancer. While evidence supports its potential, more research is needed to fully understand its effects on head and neck cancer specifically. ^{2 3 4 6 7}

Who Is on the Research Team?

Rupali Nabar

Principal Investigator

Chao Family Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5464477/

The Effects of Active Hexose Correlated Compound (AHCC ... The Effects of Active Hexose Correlated Compound (AHCC) on Levels of CD4+ and CD8+ in Patients with Epithelial Ovarian Cancer or Peritoneal Cancer Receiving ...

2. drugs.com drugs.com/npp/ahcc.html

AHCC Uses, Benefits & Dosage AHCC has been used as a supplement for patients with cancer, HIV/AIDS, hepatitis C, hypertension, and autoimmune diseases.

3. cancertherapyadvisor.com cancertherapyadvisor.com/factsheets/ahcc-and-cancer/

AHCC and Cancer Active hexose correlated compound enhances tumor surveillance through regulating both innate and adaptive immune responses. Cancer Immunol ...

4. mskcc.org mskcc.org/cancer-care/integrative-medicine/herbs/ahcc

AHCC | Memorial Sloan Kettering Cancer ... AHCC is a group of chemicals that are taken from fungi, like mushrooms, and turned into a supplement. People take this supplement to help their immune system.

5. verywellhealth.com verywellhealth.com/ahcc-benefits-and-safety-8400769

Does AHCC Really Offer Health Benefits? The medicinal mushroom supplement AHCC has been studied for boosting the immune system and protecting against cancer. Learn more.

6. rxlist.com rxlist.com/supplements/ahcc.htm

Ahcc: Health Benefits, Side Effects, Uses, Dose & ... Learn more about Ahcc health benefits, uses, side effects, effectiveness, safety, precautions, and warnings.

7. dsld.od.nih.gov dsld.od.nih.gov/label/43951

Kinoko Gold AHCC Active Hexose Correlated Compound Product overview and label information for Kinoko Gold AHCC Active Hexose Correlated Compound in the NIH Dietary Supplement Label Database (DSLD).