High Risk Human Papillomavirus InfectionNCT04633330
Evaluation of AHCC® for the Clearance of High Risk-HPV Infections in Chinese Female
A study testing AHCC®capsules and Simulation of AHCC®capsules in people with High Risk Human Papillomavirus Infection and Low Grade Squamous Intraepithelial Lesion, run by Shandong University at 1 site in China.
Trial 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®. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- High Risk Human Papillomavirus Infection, Low Grade Squamous Intraepithelial Lesion
- What is being tested?
- AHCC®capsules and Simulation of AHCC®capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Beihua Kong, MD. PhD., +8618560081888, kongbeihua@sdu.edu.cn
About this study
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
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®.
Read the 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.
- Being tested
- AHCC®capsules, Simulation of AHCC®capsules
- Keywords
- HR-HPV, AHCC®
- Medical subject headings
- Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHCC®capsulesDrug
Also called Yinuojin Ruanjiaonang
AHCC®capsules, a standardized extract of cultured Lentinula edodes mycelia (ECLM) TID for 6 months after enrolment.
Simulation of AHCC®capsulesDrug
Also called Yinuojin Ruanjiaonang Moniji
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | AHCC®capsules, 5 capsules * 3 times per day, empty stomach (defined as one hour before meal or two hours after meal). Receives: Drug: AHCC®capsules |
| Control Arm | Placebo comparator | Simulation of AHCC®capsules, 5 capsules * 3 times per day, empty stomach (defined as one hour before meal or two hours after meal). Receives: Drug: Simulation of AHCC®capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months for all participants since enrolment
Secondary outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start26 Oct 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Human Papillomavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University
- Responsible party
- Principal investigator, Beihua Kong, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633330
- Sponsor's protocol ID
- AHCC-WM-0520
- Status last verified
- Jan 2024
- First submitted
- 26 Oct 2020
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The desensitised protocol and metadata will be publicly available after completion.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04633330
- Acronym / sponsor ID
- AHCC-WM-0520
- Keywords
- HR-HPV, AHCC®
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Drug: AHCC®capsulesAHCC®capsules, 5 capsules * 3 times per day, empty stomach (defined as one hour before meal or two hours after meal). |
| Control Arm | Placebo comparator | Drug: Simulation of AHCC®capsulesSimulation of AHCC®capsules, 5 capsules * 3 times per day, empty stomach (defined as one hour before meal or two hours after meal). |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AHCC®capsulesAlso: Yinuojin RuanjiaonangAHCC®capsules, a standardized extract of cultured Lentinula edodes mycelia (ECLM) TID for 6 months after enrolment. | Drug | Study Arm |
| Simulation of AHCC®capsulesAlso: Yinuojin Ruanjiaonang MonijiTID 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. | Drug | Control Arm |
Primary outcome
High risk human papillomavirus (HR-HPV) infection testing, ROCHE, Cobas assay
Time frame: 6 months for all participants since enrolment
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.
1 secondary outcome
Interferon Beta Test-Plasma
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: Yes. The desensitised protocol and metadata will be publicly available after completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AHCC®capsules and Simulation of AHCC®capsules in people with High Risk Human Papillomavirus Infection and Low Grade Squamous Intraepithelial Lesion, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High risk human papillomavirus (HR-HPV) infection testing, ROCHE, Cobas assay (time frame: 6 months for all participants since enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.