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

Trial Summary

What is the purpose of this trial?

This is a pilot phase, randomized, double-blinded feasibility pilot study of AHCC in participants with ovarian cancer.

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.

What data supports the effectiveness of the drug AHCC when used with chemotherapy for ovarian cancer?

The study found that while AHCC did not significantly change CD4+ and CD8+ T cell levels overall, CD8+ levels were higher in the AHCC group at the sixth cycle of chemotherapy, and it reduced nausea and vomiting, suggesting some potential benefits when used with chemotherapy. ^{1 2 3 4 5}

Is the combination of AHCC and chemotherapy safe for humans?

In a study with ovarian cancer patients, AHCC combined with chemotherapy showed no significant difference in immune cell levels compared to a placebo, and it reduced nausea and vomiting but increased muscle pain. Overall, it appears to be generally safe with some manageable side effects. ^{1 2 6 7 8}

What makes the AHCC + Chemotherapy treatment unique for ovarian cancer?

The AHCC + Chemotherapy treatment is unique because it combines standard chemotherapy with Active Hexose Correlated Compound (AHCC), which is believed to enhance the immune system and reduce some side effects of chemotherapy, such as nausea and vomiting, while potentially increasing certain immune cells (CD8+ T cells) during treatment. ^{1 2 6 9 10}

Research Team

Hui Chen, MD

Principal Investigator

University of California, Davis

Eligibility Criteria

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

I do not have any unmanaged ongoing illnesses.

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

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]

References

1. Thailand 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 [2019]

2. United States 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. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Are there candidates for high-dose chemotherapy in ovarian carcinoma? [2021]

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

Optimizing primary chemotherapy in ovarian cancer. [2019]

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

Ovarian cancer. [2019]

6. England 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. [2015]

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

First-line chemotherapy with epidoxorubicin, paclitaxel, and carboplatin for the treatment of advanced epithelial ovarian cancer patients. [2019]

8. United States 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. [2023]

9. England 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. [2022]

10. England 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. [2022]