AHCC + Chemotherapy for Ovarian Cancer

Overseen By Selina Laqui, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of California, Davis

Must be taking: Platinum, Taxane

Must not be taking: Immunosuppressants

Disqualifiers: Mushroom allergy, Immunosuppressants, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 9-18 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding AHCC, a mushroom extract, to standard chemotherapy is safe and effective for treating ovarian cancer. Participants will receive either AHCC or a placebo (a harmless pill resembling the real treatment) alongside their chemotherapy. This study suits those diagnosed with ovarian cancer who are already scheduled for chemotherapy. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant advancements in ovarian cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive medications, you may need to stop them unless they fall under certain exceptions like low-dose or specific types of steroids.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Active Hexose Correlated Compound (AHCC) is generally safe for most people. AHCC, a mushroom extract, is often used as a supplement for various conditions, including cancer, and may help boost the immune system.

In studies, most participants taking AHCC did not experience serious side effects. Some reported mild stomach discomfort or changes in bowel habits, but these effects are common and usually not serious.

This is a Phase 2 trial, indicating that earlier studies found AHCC safe enough for further testing. While every treatment can have side effects, past research suggests AHCC has a promising safety profile.

Participants should always consult a healthcare provider about any concerns or questions before joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

Researchers are excited about AHCC for ovarian cancer because it introduces a novel approach by using a standardized extract of cultured Lentinula edodes mycelia, commonly known as AHCC. Most current treatments for ovarian cancer rely on chemotherapy, which works by killing rapidly dividing cells but can also harm healthy cells. AHCC is derived from shiitake mushrooms and may boost the immune system, potentially enhancing the body's natural defenses against cancer. This unique mechanism could complement traditional chemotherapy, offering a dual approach that targets cancer cells while supporting immune health.

What evidence suggests that this trial's treatments could be effective for ovarian cancer?

Research suggests that AHCC (Active Hexose Correlated Compound), which participants in this trial may receive, might help strengthen the immune system in patients with ovarian cancer. Studies have shown that AHCC can increase the number of CD4+ and CD8+ T cells, which are crucial for fighting cancer. Patients with cancer who took AHCC had higher levels of these T cells after chemotherapy. AHCC has also been used for conditions like HIV/AIDS and hepatitis C, indicating broader immune benefits. While most of this information comes from studies on immune response, it is an early sign that AHCC could support cancer treatment. ^{1 2 6 7 8}

Who Is on the Research Team?

Hui Chen, MD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking adults with ovarian, fallopian tube, or peritoneal cancer who are undergoing standard chemotherapy. They must have good organ and bone marrow function, not be allergic to mushrooms or certain other substances, and agree to use contraception if of child-bearing potential. HIV-positive patients can join if they meet specific criteria.

Inclusion Criteria

Individuals of child-bearing potential must agree to use adequate contraception

I can take care of myself but might not be able to do heavy physical work.

I can take Bevacizumab.

Exclusion Criteria

I do not have any unmanaged ongoing illnesses.

I have used certain immune-weakening medications in the last 3 months.

Any condition that would prohibit the understanding or rendering of informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AHCC or placebo daily during standard of care chemotherapy

9-18 weeks

Visits coincide with chemotherapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AHCC
• Chemotherapy
• Placebo

Trial Overview The study tests AHCC (a mushroom extract) versus a placebo in ovarian cancer patients receiving adjuvant chemotherapy. It's a pilot phase trial where participants are randomly assigned to either the AHCC group or the placebo group without knowing which one they're getting.

How Is the Trial Designed?

Group I: Standardized Extract of Cultured Lentinula Edodes Mycelia (AHCC®) Experimental Treatment 2 Interventions

AHCC 3g PO Daily

Group II: Placebo Placebo Group 2 Interventions

Placebo PO Daily

Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in United States as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Canada as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Japan as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in China as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Switzerland as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Amino Up Chemicals Co., Ltd.

Industry Sponsor

Trials

3

Recruited

110+

Published Research Related to This Trial

Olaparib maintenance therapy demonstrated good efficacy in patients with high-grade serous ovarian cancer, with 3.84% achieving complete response and 7.69% showing partial response, while also improving quality of life across various domains.

The treatment was generally well-tolerated, with most adverse events being Grade 1 and 2, although 16.32% of patients experienced Grade 3 anemia and 20.40% experienced neutropenia, leading to dose reductions in 73.40% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of adverse events and quality of life in high-grade serous ovarian cancer patients with Olaparib maintenance therapy: A single-center study in China. Jiang, Y., Xu, T., Yuan, L., et al.[2023]

Primary chemotherapy for advanced ovarian cancer typically involves a combination of platinum agents (like carboplatin or cisplatin) and taxanes (such as paclitaxel or docetaxel), leading to a favorable response in 60% to 80% of patients.

Future research aims to integrate new cancer-fighting drugs into standard treatments to improve effectiveness, enhance quality of life, and extend survival for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing primary chemotherapy in ovarian cancer. Markman, M.[2019]

Cisplatin-based combination chemotherapy has improved remission rates and median survival for ovarian cancer, but 5-year survival rates for advanced stages remain low at 25-30%.

New treatment strategies being explored to enhance survival rates include high-dose carboplatin, intraperitoneal chemotherapy, and the use of new agents like Taxol and Ifosfamide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovarian cancer. Ozols, RF.[2019]

In a study involving 247 patients with advanced ovarian cancer, both treatment regimens (standard carboplatin plus paclitaxel and alternating carboplatin/cisplatin plus paclitaxel) showed similar efficacy, with no significant differences in progression-free survival (PFS) or overall survival.

Both regimens were well tolerated, indicating that while the alternating regimen does not provide additional benefits, it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel plus carboplatin versus paclitaxel plus alternating carboplatin and cisplatin for initial treatment of advanced ovarian cancer: long-term efficacy results: a Hellenic Cooperative Oncology Group (HeCOG) study. Aravantinos, G., Fountzilas, G., Kosmidis, P., et al.[2022]

In a study of 451 patients with advanced ovarian cancer, the combination of Cisplatin, Paclitaxel, and Doxorubicin showed a marginal improvement in progression-free survival (PFS) compared to the standard Carboplatin and Paclitaxel regimen, although there was no difference in overall survival.

The anthracycline combination resulted in better performance status but was associated with a higher incidence of febrile neutropenia, indicating a trade-off between potential benefits and increased toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carboplatin and paclitaxel versus cisplatin, paclitaxel and doxorubicin for first-line chemotherapy of advanced ovarian cancer: a Hellenic Cooperative Oncology Group (HeCOG) study. Aravantinos, G., Fountzilas, G., Bamias, A., et al.[2022]

The combination of epidoxorubicin, paclitaxel, and carboplatin (ETC) showed a high response rate of 86% in advanced ovarian cancer patients, with 64% achieving a complete response and 21% a partial response, based on a study of 50 evaluable patients.

The ETC regimen resulted in a median overall survival of 36 months and a median progression-free survival of 19.5 months, indicating its potential effectiveness for patients with advanced ovarian cancer, despite common side effects like severe leukopenia and thrombocytopenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-line chemotherapy with epidoxorubicin, paclitaxel, and carboplatin for the treatment of advanced epithelial ovarian cancer patients. Romanini, A., Tanganelli, L., Carnino, F., et al.[2019]

In a study of 28 patients with epithelial ovarian cancer undergoing chemotherapy, those taking Active Hexose Correlated Compound (AHCC) showed a significant increase in CD8+ T cell lymphocyte levels by the sixth cycle of treatment, suggesting a potential immunoenhancing effect.

While AHCC did not significantly improve overall CD4+ and CD8+ T cell levels compared to placebo, it was associated with a reduction in nausea and vomiting during chemotherapy, although it also led to increased muscle pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Active Hexose Correlated Compound (AHCC) on Levels of CD4+ and CD8+ in Patients with Epithelial Ovarian Cancer or Peritoneal Cancer Receiving Platinum Based Chemotherapy Suknikhom, W., Lertkhachonsuk, R., Manchana, T.[2019]

In a multicenter phase I/II trial involving 48 patients with untreated ovarian cancer, high-dose chemotherapy (HDCT) was found to be feasible, with manageable toxicity levels, particularly when carboplatin was limited to AUC 20 and etoposide was eliminated.

At a median follow-up of 8 years, patients experienced a median progression-free survival of 13.3 months and overall survival of 37.0 months, indicating that HDCT may offer a potential benefit in treating advanced ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II trial of multicycle high-dose chemotherapy with peripheral blood stem cell support for treatment of advanced ovarian cancer. Frickhofen, N., Berdel, WE., Opri, F., et al.[2015]

In a study comparing 103 advanced ovarian carcinoma patients treated with conventional chemotherapy to 60 patients receiving high-dose chemotherapy (HDC), no overall survival advantage was found for the HDC group across the entire population.

However, young patients (≤50 years) showed improved outcomes with HDC, including better progression-free survival and overall survival, suggesting that HDC may be beneficial for this specific age group after standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are there candidates for high-dose chemotherapy in ovarian carcinoma? Sabatier, R., Gonçalves, A., Bertucci, F., et al.[2021]

In a study of 22 patients with advanced ovarian adenocarcinoma, the HAC therapy (hexamethylmelamine, doxorubicin, and cis-dichlorodiamine-platinum) showed an 82% response rate in patients who had not received prior chemotherapy and a 50% response rate in those who had, indicating its effectiveness regardless of previous treatments.

The median survival for patients treated with HAC was 16 months, and the therapy was associated with low major toxicities, primarily affecting blood, nerves, and the gastrointestinal system, making it a viable outpatient treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of advanced ovarian carcinoma with hexamethylmelamine, doxorubicin, and cis-platinum (HAC): results in both untreated and previously treated patients. Brower, MS., Coleman, M., Pasmantier, MW., 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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28440968/

The Effects of Active Hexose Correlated Compound (AHCC ... The primary outcome was a change of CD4+ and CD8+ T cell lymphocytes in peripheral blood samples from baseline to completion of chemotherapy.

3. 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.

4. researchgate.net researchgate.net/publication/316488222_The_Effects_of_Active_Hexose_Correlated_Compound_AHCC_on_Levels_of_CD4_and_CD8_in_Patients_with_Epithelial_Ovarian_Cancer_or_Peritoneal_Cancer_Receiving_Platinum_Based_Chemotherapy

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 ...

5. youtube.com youtube.com/watch?v=58WYd_ZHc8c

Ovarian Cancer and AHCC Study - A Discussion with Dr. ... Beat Cancer hosts Chris Joyce and Stephanie Winn sit down with Dr. Amy Chen, Assistant Clinical Professor in the Division of Gynecologic ...

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

7. 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 ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20951179/

Genotoxicity and subchronic toxicity evaluation of Active ... Active Hexose Correlated Compound (AHCC), a mushroom extract rich in α-1,4 linked glucans, is associated with immunostimulatory effects.