Standardized Extract of Cultured Lentinula Edodes Mycelia (AHCC®) in Ovarian Cancer Patients on Adjuvant Chemotherapy

NCT05763199 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: UCDCC#302
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peritoneal Carcinoma; Ovarian Epithelial Carcinoma; Fallopian Tube Carcinoma

Keywords

AHCC; Standardized extract of cultured Lentinula edodes mycelia

Outcome Measures

Primary Outcomes (3)

• Proportion of participants consent and randomized to taking AHCC or placebo during adjuvant chemotherapy compared to to total number of ovarian cancer patients eligible for the trial following prescreening and participation invitation.

  Study activation to randomization of 20th participant

• Time required to randomize 20 participants

  Study activation to randomization of 20th participant.

• Proportion of participants that complete study treatment

  First dose through Cycle 3-6 post adjuvant chemotherapy; each cycle is 3 weeks

Secondary Outcomes (6)

• Proportion of participants that adhere to taking study treatment

  First dose through Cycle 3-6 post adjuvant chemotherapy; each cycle is 3 weeks

• Adherence to taking study treatment for each participant

  First dose through Cycle 3-6 post adjuvant chemotherapy; each cycle is 3 weeks

• Proportion of participants that adhere to completing the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)

  Baseline through 30d post last dose

• Proportion of participants that adhere to completing the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group - Neurotoxicity (FACT/ GOG-NTX)

  Baseline through 30d post last dose

• Proportion of participants that adhere to completing the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)

  Baseline through 30d post last dose

Study Arms (2)

Standardized Extract of Cultured Lentinula Edodes Mycelia (AHCC®)

EXPERIMENTAL

AHCC 3g PO Daily

Dietary Supplement: AHCC; Drug: Chemotherapy

Placebo

PLACEBO COMPARATOR

Placebo PO Daily

Drug: Chemotherapy; Other: Placebo

Interventions

AHCC DIETARY_SUPPLEMENT

AHCC is the cultured mycelia of Lentinula edodes mushrooms from the Basidiomycetes family.

Also known as: A standardized extract of cultured Lentinula edodes mycelia

Standardized Extract of Cultured Lentinula Edodes Mycelia (AHCC®)

Chemotherapy DRUG

Chemotherapy will be administered per standard of care.

Also known as: Platinum and taxane chemotherapy

Placebo; Standardized Extract of Cultured Lentinula Edodes Mycelia (AHCC®)

Placebo OTHER

Dextrin

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed epithelial ovarian, fallopian tube or peritoneal carcinoma
• High-grade or low-grade serous, mucinous, endometrioid, clear cell, mixed or other histologies allowed
• Clinical stage I-IV at diagnosis
• 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.
• Neoadjuvant chemotherapy is allowed (no washout period will be required)
• Any combination of platinum and taxane doublet is allowed (i.e., carboplatin, cisplatin, paclitaxel, or docetaxel)
• Different schedules of platinum and taxane doublet are allowed (i.e., every 21 days, dose-dense or weekly)
• Bevacizumab is allowed
• Age greater than or equal to 18 years of age
• English or Spanish-speaking individuals
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60%)
• Organ and bone marrow function defined by:
• Leukocytes greater than or equal to 2,500/µL
• Absolute neutrophil count greater than or equal to 1,000/µL
• Platelets greater than or equal to 75,000/µL

You may not qualify if:

• History of allergic reactions to mushrooms
• History of allergic reaction to dextrin
• History of allergic reaction to rapeseed oil
• History of allergic reaction to corn
• Consumption of other supplements derived from mushrooms or basidiomycetes
• Consumption of whole mushrooms through diet is acceptable
• Consumption of a blend with unknown/ unclear mushrooms or basidiomycetes contents, then it is ok to include participant
• Current or prior (within 3 months of enrollment) use of immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) agents). The following are exceptions to this criterion:
• Intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10 mg/day of prednisone or equivalent may be enrolled.
• Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled.
• The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would interfere with patient safety or limit compliance with study requirements.
• Inability to swallow experimental agent or placebo
• History of gastrectomy or other malabsorption syndromes
• Subjects who are pregnant or breast-feeding

Sponsors & Collaborators

• University of California, Davis: lead
• Amino Up Chemicals Co., Ltd.: collaborator

Study Sites (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

Drug Therapy; Platinum

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Hui Chen, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: March 10, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)