AHCC + Chemotherapy for Ovarian Cancer
Recruiting in Palo Alto (17 mi)
Overseen byHui Chen, MD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of California, Davis
Must be taking: Platinum, Taxane
Must not be taking: Immunosuppressants
Disqualifiers: Mushroom allergy, Immunosuppressants, others
Prior Safety Data
Approved in 6 Jurisdictions
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.
12345Is 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.
12678What 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.
126910Eligibility 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.
+11 more
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
+6 more
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Standardized Extract of Cultured Lentinula Edodes Mycelia (AHCC®)Experimental Treatment2 Interventions
AHCC 3g PO Daily
Group II: PlaceboPlacebo Group2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California Davis Comprehensive Cancer CenterSacramento, CA
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Who Is Running the Clinical Trial?
University of California, DavisLead Sponsor
National Cancer Institute (NCI)Collaborator
Amino Up Chemicals Co., Ltd.Industry Sponsor
References
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]Background: Adjuvant chemotherapy is a required treatment for most patients with epithelial ovarian cancer (EOC) or peritoneal cancer. However, it has many adverse events which may affect oncologic outcomes. Active hexose correlated compound (AHCC) has been reported to be an immunoenhancer to decrease adverse events of chemotherapy. Materials and Methods: Patients were randomized and allocated to receive either AHCC three grams/day (500mg/ capsule) or placebo. These drugs were administrated as two capsules orally three times a day throughout six cycles of chemotherapy. The primary outcome was a change of CD4+ and CD8+ T cell lymphocytes in peripheral blood samples from baseline to completion of chemotherapy. Secondary outcomes were rate of bone marrow suppression, adverse events and quality of life (QOL) as assessed by Thai version of the Functional Assessment of Cancer Therapy-General (FACT-G). Results: Study outcomes were analyzed in 28 patients, 14 patients in each group. Changes in CD4+ and CD8+ T cell lymphocytes levels were not significantly different between AHCC and placebo group; 43.5/ul (-237.5, 143.3) versus -69.5 /ul (-223.8, 165) for CD4+ level, p=0.61 and 49.5.0 /ul (-80, 153.3) versus 4.0 /ul (-173, 62.5) for CD8+ level, p=0.19. However, CD8+ levels were significantly higher in the AHCC group at the sixth cycle of chemotherapy; 392.5.0 /ul (310.8, 598) versus 259.5 /ul (170.5, 462.3), p=0.03. There was no difference in bone marrow suppression and QOL between the two groups. Adverse events in terms of nausea and vomiting significantly decreased but muscle pain significantly increased in the AHCC group. Conclusions: Changes in CD4+ and CD8+ T cell lymphocytes from baseline were not significantly increased in AHCC group. However, CD8+T cell lymphocytes levels were significantly higher in the AHCC group at the sixth cycle of chemotherapy.
Treatment of advanced ovarian carcinoma with hexamethylmelamine, doxorubicin, and cis-platinum (HAC): results in both untreated and previously treated patients. [2019]Twenty-two patients with advanced (FIGO stages III and IV) adenocarcinoma of the ovary were treated with 28-day cycles of hexamethylmelamine, doxorubicin, and cis-dichlorodiamine-platinum (II) (HAC). After 45 months, there were 21 evaluable patients. The median survival was 16 months. Response was achieved in 82% (9/11) who had received no prior chemotherapy, and in 50% (5/10) previously treated. HAC therapy was readily administered on an outpatient basis, with comparatively low major toxicities, primarily hematologic, neurologic, and gastrointestinal. These results indicate that HAC therapy is an effective regimen for patients with advanced ovarian carcinoma, regardless of their prior treatment status.
Are there candidates for high-dose chemotherapy in ovarian carcinoma? [2021]Prognosis of advanced ovarian carcinomas (AOC) remains poor with a 5-year survival of 30%. Benefit from high-dose chemotherapy (HDC) in this disease has not been demonstrated to date.
Optimizing primary chemotherapy in ovarian cancer. [2019]Primary chemotherapy for advanced ovarian cancer includes the administration of a platinum agent (carboplatin or cisplatin) and a taxane (paclitaxel or docetaxel). Most patients (60% to 80%) experience subjective and objective evidence of a favorable response, with prolonged disease-free and overall survival being noted in a substantial subset of this population. Future investigative efforts will focus on the incorporation of new and novel antineoplastic agents into standard treatment, with the important goals of improving biologic activity, enhancing overall quality of life, and extending survival.
Ovarian cancer. [2019]Even though cisplatin-based combination chemotherapy results in increased clinical and surgical complete remission rates and improved median survival compared with single-agent alkylating agent chemotherapy, the 5 year survival rates for stages III and IV ovarian cancer have only improved to 25-30%. New methods being evaluated to improve response rates, median survival, and 5 year survival rates include the use of high-dose carboplatin, dose intensity using platinum compounds, intraperitoneal chemotherapy, concomitant intravenous and intraperitoneal chemotherapy, and the recent discovery of new active agents against epithelial ovarian cancer--Taxol, and Ifosfamide plus mesna.
Phase I/II trial of multicycle high-dose chemotherapy with peripheral blood stem cell support for treatment of advanced ovarian cancer. [2015]Ovarian cancer is chemosensitive, but most patients with advanced disease die from tumor progression. As 25% of the patients can be cured by chemotherapy, it is reasonable to evaluate high-dose chemotherapy (HDCT). Forty-eight patients with untreated ovarian cancer were entered in a multicenter phase I/II trial of multicycle HDCT. Median age was 46 (19-59 years); International Federation of Gynecology and Obstetrics-stage was III in 79% and IV in 21%; 31% had residual disease >1 cm after surgery. Two courses of induction/mobilization therapy with cyclophosphamide (250 mg/m2) and paclitaxel (250 mg/m2) were used to collect peripheral blood stem cells. HDCT consisted of two courses of carboplatin (area under curve (AUC) 18-22) and paclitaxel followed by one course of carboplatin and melphalan (140 mg/m2) with or without etoposide (1600 mg/m2). Main toxicity was gastrointestinal. Limiting carboplatin to AUC 20 and eliminating etoposide resulted in manageable toxicity (69% without grade 3/4 toxicity). One patient died from treatment-related pneumonitis. At 8 years median follow-up, median progression-free-survival (PFS) and overall survival (OS) is 13.3 and 37.0 months. Five-years PFS and OS is 18 and 33%. Multicycle HDCT is feasible in a multicenter setting. A European phase III trial based on this regimen is evaluating the efficacy of HDCT.
First-line chemotherapy with epidoxorubicin, paclitaxel, and carboplatin for the treatment of advanced epithelial ovarian cancer patients. [2019]A combination of carboplatin (CBDCA) and paclitaxel (TAX) is the standard treatment in advanced ovarian cancer (AOC) patients. Epidoxorubicin (EDX) is an active treatment in AOC and exhibits nonoverlapping toxicities with CBDCA and TAX; moreover, when added to platinum-based chemotherapy, it improves long-term survival. We have therefore conducted a phase II study to evaluate the tolerability and antitumor activity of an EDX/TAX/CBDCA (ETC) triplet in AOC patients.
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]Olaparib showed good efficacy and tolerability in the maintenance treatment of patients with initial therapy or high-grade serous recurrent ovarian cancer patients. This study aimed to analyze adverse events (AEs) of patients taking Olaparib and the quality of life (QoL) with Olaparib in 1 center of China. The study included 98 patients who received Olaparib and 210 patients without Olaparib from July 2018 to October 2021 for high-grade serous ovarian cancer in the Gynecology Oncology Department of Jiangsu Provincial Hospital. Information of clinicopathologic characteristics was collected from medical records. Then, we used the QLQ-C30 and Quality of Life Ovarian Cancer 28 Questionnaire (QLQ-OV28) to determine the QoL of 98 patients with and 210 patients without Olaparib. Among all 98 patients with Olaparib, 66 patients in first-line and 32 patients in more than second-line treatment. Regarding the best objective response with Olaparib maintenance in 78 patients with partial remission from most recent chemotherapy, 3 (3.84%) patients showed complete response (CR) and 6 (7.69%) showed as partial response (PR), whereas stable disease was observed in 42 patients (53.84%) and 27 patients (34.6%) showed as progression disease. AEs of Grade 3 and more were: anemia in 16 patients (16.32%), neutropenia in 20 patients (20.40%), thrombocytopenia in 4 patients (4.08%), and headache in 4 patients (4.08%). Dose reduction and drug discontinuation accounted for 73.40% and 20.40%, respectively. Olaparib as maintenance therapy increased QoL on all functioning domains and several symptom domains. Consistent with previous clinical trials, Olaparib maintenance therapy was proved safe and effective. Most patients may experience Grade 1 and 2 AEs. Olaparib maintenance therapy can increase QoL in several domains.
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]We compared the combination plus Carboplatin plus paclitaxel, which is considered the treatment of choice for initial chemotherapy of advanced ovarian cancer (AOC) with a regimen combining alternating carboplatin and cisplatin plus paclitaxel. The two platinum derivatives have been previously combined as they are not totally cross-resistant and as they share no overlapping toxicities.
Carboplatin and paclitaxel versus cisplatin, paclitaxel and doxorubicin for first-line chemotherapy of advanced ovarian cancer: a Hellenic Cooperative Oncology Group (HeCOG) study. [2022]The combination of Carboplatin and Paclitaxel is considered the standard of care as initial chemotherapy for Advanced Ovarian Cancer (AOC). We compared this regimen with the combination of Cisplatin, Paclitaxel and Doxorubicin.