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Chemotherapy

AHCC + Chemotherapy for Ovarian Cancer

Phase 2
Recruiting
Led By Hui Chen, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60%)
Bevacizumab is allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study activation to randomization of 20th participant, which is estimated to be up to 1 year post study activation
Awards & highlights

Study Summary

This trial tests if AHCC can help treat ovarian cancer. Results will show if it's a safe and effective option.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of AHCC aren't detailed here, typical risks may include allergic reactions given its mushroom origin. Chemotherapy side effects often involve fatigue, nausea, hair loss, increased infection risk and blood cell count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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I can take Bevacizumab.
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I am on a platinum and taxane treatment schedule.
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I am set to receive standard chemotherapy with platinum and taxane after surgery.
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I have been treated with a combination of platinum and taxane drugs.
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I am 18 years old or older.
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My organ and bone marrow functions are within normal ranges.
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I speak English or Spanish.
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I have received chemotherapy before surgery without needing a break.
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My cancer is confirmed in the ovary, fallopian tube, or peritoneum.
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My cancer was stage I-IV when first diagnosed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study activation to randomization of 20th participant, which is estimated to be up to 1 year post study activation
This trial's timeline: 3 weeks for screening, Varies for treatment, and study activation to randomization of 20th participant, which is estimated to be up to 1 year post study activation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants randomized to taking AHCC or placebo during adjuvant chemotherapy
Proportion of participants that complete study treatment
Time required to randomize 20 participants
Secondary outcome measures
Adherence to taking study treatment for each participant
Participant experience self-reported in the acceptability questionnaire compared to self-reported anticipated acceptability
Proportion of participants that adhere to completing the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
+3 more

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
909 Previous Clinical Trials
4,704,110 Total Patients Enrolled
Amino Up Chemicals Co., Ltd.Industry Sponsor
1 Previous Clinical Trials
47 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,815 Total Patients Enrolled

Media Library

Chemotherapy (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05763199 — Phase 2
Fallopian Tube Cancer Research Study Groups: Standardized Extract of Cultured Lentinula Edodes Mycelia (AHCC®), Placebo
Fallopian Tube Cancer Clinical Trial 2023: Chemotherapy Highlights & Side Effects. Trial Name: NCT05763199 — Phase 2
Chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05763199 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor still seeking participants?

"According to information posted on clinicaltrials.gov, registration for this trial has been closed since February 27th 2023. However, 2805 other trials are currently recruiting patients and may be suitable alternatives."

Answered by AI

Has the FDA given its stamp of approval to Standardized Extract of Cultured Lentinula Edodes Mycelia (AHCC®)?

"Our team at Power evaluated the safety of Standardized Extract of Cultured Lentinula Edodes Mycelia (AHCC®) as a 2, due to prior clinical data supporting its safety but none concerning efficacy."

Answered by AI
~13 spots leftby Apr 2026