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

Primary Purpose

High Risk Human Papillomavirus Infection, Low Grade Squamous Intraepithelial Lesion

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

AHCC®capsules

Simulation of AHCC®capsules

About this trial

This is an interventional treatment trial for High Risk Human Papillomavirus Infection focused on measuring HR-HPV, AHCC®

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Qilu Hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Arm

Control Arm

Arm Description

AHCC®capsules, 5 capsules * 3 times per day, empty stomach (defined as one hour before meal or two hours after meal).

Simulation of AHCC®capsules, 5 capsules * 3 times per day, empty stomach (defined as one hour before meal or two hours after meal).

Outcomes

Primary Outcome Measures

High risk human papillomavirus (HR-HPV) infection testing, ROCHE, Cobas assay

The Cobas human papillomavirus (HPV) test is NMPA-approved for cervical and endocervical samples collected in PreservCyt (ThinPrep) media. The Cobas HPV test detects DNA of the high-risk types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. This test does not detect DNA of HPV low-risk types (e.g., 6, 11, 42, 43, 44) since these are not associated with cervical cancer and its precursor lesions.

Secondary Outcome Measures

Interferon Beta Test-Plasma

Human IFN-β (Interferon beta) ELISA Kit will be applied for this test. This kit was based on sandwich enzyme-linked immune-sorbent assay technology. Capture antibody was precoated onto 96-well plates. And the biotin conjugated antibody was used as detection antibodies. The standards, test samples and biotin conjugated detection antibody were added to the wells subsequently, and washed with wash buffer. HRP-Streptavidin was added and unbound conjugates were washed away with wash buffer. TMB substrates were used to visualize HRP enzymatic reaction. TMB was catalysed by HRP to produce a blue colour product that changed into yellow after adding acidic stop solution. The density of yellow is proportional to the target amount of sample captured in plate. Read the O.D. absorbance at 450nm in a microplate reader, and then the concentration of target can be calculated.

Full Information

NCT ID

NCT04633330

First Posted

October 26, 2020

Last Updated

April 22, 2023

Sponsor

Shandong University

Collaborators

Qilu Hospital of Shandong University

1. Study Identification

Unique Protocol Identification Number

NCT04633330

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 26, 2020 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

Collaborators

Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High Risk Human Papillomavirus Infection, Low Grade Squamous Intraepithelial Lesion

Keywords

HR-HPV, AHCC®

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study Arm

Arm Type

Experimental

Arm Description

AHCC®capsules, 5 capsules * 3 times per day, empty stomach (defined as one hour before meal or two hours after meal).

Arm Title

Control Arm

Arm Type

Placebo Comparator

Arm Description

Simulation of AHCC®capsules, 5 capsules * 3 times per day, empty stomach (defined as one hour before meal or two hours after meal).

Intervention Type

Drug

Intervention Name(s)

AHCC®capsules

Other Intervention Name(s)

Yinuojin Ruanjiaonang

Intervention Description

AHCC®capsules, a standardized extract of cultured Lentinula edodes mycelia (ECLM) TID for 6 months after enrolment.

Intervention Type

Drug

Intervention Name(s)

Simulation of AHCC®capsules

Other Intervention Name(s)

Yinuojin Ruanjiaonang Moniji

Intervention Description

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.

Primary Outcome Measure Information:

Title

High risk human papillomavirus (HR-HPV) infection testing, ROCHE, Cobas assay

Description

Time Frame

6 months for all participants since enrolment

Secondary Outcome Measure Information:

Title

Interferon Beta Test-Plasma

Description

Time Frame

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 Pre-specified Outcome Measures:

Title

Liquid based cytology test

Description

In this method, the cervical cells are immersed in a conserving liquid before being fixed on the slide, avoiding desiccation and reducing the quantity of obscuring material. Liquid cytology can be prepared by manual or automated methods, and various systems are commercially available. They are mostly used for cervical cancer screening but are also adapted for FNAC samples.

Time Frame

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Qilu Hospital of Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beihua Kong, MD. PhD.

Phone

+8618560081888

kongbeihua@sdu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The desensitised protocol and metadata will be publicly available after completion.

IPD Sharing Time Frame

The sharing data will be available after Dec. 2021.

Learn more about this trial

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

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