NCT05763199

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

Feasibility Pilot Study of a Standardized Extract of Cultured Lentinula Edodes Mycelia (AHCC®) on Quality of Life for Ovarian Cancer Patients on Adjuvant Chemotherapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a pilot phase, randomized, double-blinded feasibility pilot study of AHCC in participants with ovarian cancer. 20 women who plan to undergo adjuvant chemotherapy for ovarian cancer at the University of California (UC) Davis Health Comprehensive Cancer Center will be enrolled and randomized 1:1 to receive AHCC (3 grams by mouth daily) or placebo during standard of care chemotherapy. HRQOL and adverse events will be assessed at baseline and during chemotherapy. The hypothesis is that a randomized controlled trial of AHCC supplementation for ovarian cancer patients on adjuvant chemotherapy is feasible.

Conditions

• Ovarian Epithelial Carcinoma
• Fallopian Tube Carcinoma
• Peritoneal Carcinoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	AHCC	AHCC is the cultured mycelia of Lentinula edodes mushrooms from the Basidiomycetes family.
DRUG	Chemotherapy	Chemotherapy will be administered per standard of care.
OTHER	Placebo	Dextrin

Timeline

• Start date: 2023-08-01
• Primary completion: 2026-12-31
• Completion: 2027-03-01
• First posted: 2023-03-10
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study