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%)

Treatment decision to include standard-of-care adjuvant chemotherapy after primary or interval debulking surgery, or initial staging surgery. Chemotherapy should include a platinum and a taxane doublet

Must not have

Uncontrolled intercurrent illness

History of gastrectomy or other malabsorption syndromes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and at end of treatment (about 9-18 weeks post adjuvant chemotherapy)

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.

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.

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 am set to receive standard chemotherapy with platinum and taxane after surgery.

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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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My cancer is confirmed in the ovary, fallopian tube, or peritoneum.

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My cancer was stage I-IV when first diagnosed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unmanaged ongoing illnesses.

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I have had surgery to remove my stomach or have a condition that affects how my body absorbs nutrients.

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I cannot swallow pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at end of treatment (about 9-18 weeks post adjuvant chemotherapy)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and at end of treatment (about 9-18 weeks post adjuvant chemotherapy)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at end of treatment (about 9-18 weeks post adjuvant chemotherapy) for reporting.