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

Last updated: January 4, 2024
Sponsor: Shandong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Simulation of AHCC®capsules

AHCC®capsules

Clinical Study ID

NCT04633330
AHCC-WM-0520
  • Ages 30-50
  • Female

Study 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®.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Sign the informed consent form
  • Not menopausal
  • Met persistent HR-HPV infection criteria:
  • At least one HR-HPV positive test over 12 months prior to screening
  • HR-HPV positive diagnosis by Cobas assay within 3 months prior to screening
  • Low grade squamous intraepithelial lesion (LSIL) diagnosis by cytology within 6 monthsprior to screening
  • Willing to take effective contraception method during study period.
  • Negative urine pregnancy test within 7 days prior to screening
  • Normal haematology, kidney and liver functions: ANC≥1,500 cells/mm3, platelets 100,000≥cells/mm3, creatinine clearance ≥60mL/min (estimated using Cockcroft Gaultequation), total bilirubin, serum alanine aminotransferase (SGPT), serum aspartateaminotransferase (SGOT), and alkaline phosphatase ≤ normal value 1.5 Times.

Exclusion

Exclusion Criteria:

  • With following medical history within 6 months prior to screening: myocardialinfarction, unstable angina, heart failure, or un-controlled hypertension (>140/90mmHg)
  • Systemic treatment for HR-HPV infection has been performed within three months beforescreening
  • Acute genital tract infection
  • Previously or currently diagnosed as malignant tumour
  • The cytological diagnosis is: ASC-H, AGC tends to become tumorous and other high-risklesions
  • The histological diagnosis is High grade squamous intraepithelial lesion (HSIL)
  • Pregnant or breastfeeding
  • A history of hepatitis (autoimmune, A, B, or C) or positive antigen
  • There is a clear history of mental confusion (schizophrenia, two-way affection,psychosis) or uncontrolled epilepsy
  • The main gynaecologist believes that there are significant medical complications,including immunosuppressive conditions (such as HIV, Rheumatoid arthritis, etc.) orare taking immunomodulators (such as immunosuppressive agents)
  • Participants with autoimmune diseases
  • Taking AHCC® capsules before screening
  • Taking other immune-modulating nutritional supplements
  • Planned hysterectomy (excluding subtotal hysterectomy)
  • Considered by investigators as unsuitable participant of this study

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Simulation of AHCC®capsules
Phase:
Study Start date:
October 26, 2020
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.