Clinical trial NCT04633330: Evaluation of AHCC® for the Clearance of High Risk-HPV Infections in Chinese Female
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Risk Human Papillomavirus Infection
Low Grade Squamous Intraepithelial Lesion
Keywords: HR-HPV
AHCC®
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University
First posted: 2020-11-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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 months prior 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 Gault equation), total bilirubin, serum alanine aminotransferase (SGPT), serum aspartate aminotransferase (SGOT), and alkaline phosphatase ≤ normal value 1.5 Times.

Exclusion Criteria:

* With following medical history within 6 months prior to screening: myocardial infarction, unstable angina, heart failure, or un-controlled hypertension (\>140/90 mmHg)
* Systemic treatment for HR-HPV infection has been performed within three months before screening
* 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-risk lesions
* 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.) or are 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

Primary outcomes:
measure: High risk human papillomavirus (HR-HPV) infection testing, ROCHE, Cobas assay
timeFrame: 6 months for all participants since enrolment
Secondary outcomes:
measure: Interferon Beta Test-Plasma
timeFrame: 3 months and 6 months for all participants since enrolment, extra-6 month for responding participant from study arm, extra 3 months and 6 months for compensated participants from control arm.
Other outcomes:
measure: Liquid based cytology test
timeFrame: 6 months for all participants since enrolment, extra-6 month for responding participant from study arm, and extra 6 months for compensated participants from control arm.
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References: