NCT04633330

Evaluation of AHCC® for the Clearance of High Risk-HPV Infections in Chinese Female

Evaluation of Efficacy of AHCC®for the Clearance of High Risk-HPV Infections in Chinese Female: A Multi-centre, Randomised, Double Blind and Placebo-controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: Female
• Age: 30 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-centre, randomised, double blind, placebo-controlled study on female participants with diagnosis of high-risk human papillomavirus (HR-HPV) infection to evaluate the clearance capacity of AHCC®.

Detailed description

Worldwide, cervical cancer is the fourth most common malignancy in women and a major cause of morbidity and mortality. It accounts for nearly 10% of all cancers. The etiology of cervical cancer has been identified and confirmed associated with high risk-human papillomavirus (HR-HPV). When HR-HPV infections persist overtime, patients have an increased risk of developing cervical cancer The proprietary, a standardized extract of cultured Lentinula edodes mycelia (ECLM), AHCC®, was developed in Japan in 1992. Several studies have reported a variety of therapeutic effects, including antioxidant and anticancer activity and improvement of immune response. As recently reported study on AHCC®, pre-clinical in vitro and in vivo evidence demonstrated its durable clearance of HR-HPV infections. The preliminary data from the two pilot studies suggested that AHCC® supplementation supports the host immune system for successful clearance of HR-HPV infections. A confirmatory phase II randomized, double-blinded, placebo-controlled study is about completion. The preliminary results of this phase II study confirmed data observed in pilot studies that AHCC® supplementation for at least 6 months is associated with a 60% successful elimination of HPV infections and confirmed IFN-β correlates with clearance of persistent HPV infections. The optimal duration of AHCC® supplementation required after the first negative result still needs more evaluation in future clinical studies. Nevertheless, all above mentioned studies have included western participants solely. The aim of this study is to evaluate the clearance capacity of AHCC® on Chinese female participants with diagnosis of HR-HPV infection.

Conditions

• High Risk Human Papillomavirus Infection
• Low Grade Squamous Intraepithelial Lesion

Interventions

Type	Name	Description
DRUG	AHCC®capsules	AHCC®capsules, a standardized extract of cultured Lentinula edodes mycelia (ECLM) TID for 6 months after enrolment.
DRUG	Simulation of AHCC®capsules	TID for 6 months after enrolment. A compensation of AHCC®is provided to participant from control arm when HR-HPV positive at 6 months after enrolment.

Timeline

• Start date: 2020-10-26
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2020-11-18
• Last updated: 2024-01-05

Locations

1 site across 1 country: China