Investigating the Effects of Mikei® Red Reishi Essence EX on the Immune System of Prostate Cancer Patients and Patients With Non-cancerous Conditions of the Prostate

March 25, 2021 updated by: Nikkei (Canada) Marketing Limited
The primary objective of this study is to determine the effects of Mikei® Red Reishi Essence EX extract powder on the immune function of prostate cancer patients and patients with non-cancerous conditions of the prostate.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to determine the effects of Mikei® Red Reishi Essence EX, a natural supplementary dietary product, on the immune function of prostate cancer patients and patients with non-cancerous conditions of the prostate. According to limited published scientific research and clinical studies, Reishi mushroom extract may support the body's immune function. According to cancer immunology research, at early stage of tumor development, the immune system can mount defensive actions to eliminate or inhibit tumor growth. This study is to examine the specific effect of Mikei® Red Reishi Essence EX on the immune function of prostate cancer patients and patients with non-cancerous conditions of the prostate.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Orlando Health Medical Group Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Male age between 50-85
  2. Diagnosed with prostate cancer or high-grade PIN within the last 24 months through the most recent biopsy; or patients who have a total PSA level above 4.0 but have not been diagnosed with prostate cancer yet
  3. Has not received any prostate cancer therapy including surgery, chemotherapy, hormone therapy, or radiation therapy
  4. Clinical Gleason score of the tumor is ≤6 for patients ≤70 years or ≤7 for >70 years; (non-applicable for non-cancer patients with elevated PSA or high-grade PIN)
  5. The clinical stage of the cancer is T1c or below (non-applicable for non-cancer patients with elevated PSA or high-grade PIN)
  6. The patients have been recommended for and placed under active surveillance without immediate treatment
  7. Able to provide written informed consent

Exclusion Criteria:

  1. Patients taking mushroom (including reishi) or other herbal products/natural supplements
  2. Patients with a known allergy to mushrooms
  3. Prisoners
  4. Patients who receive treatment with 5-alpha reductase inhibitors (finasteride [Propecia®, Proscar®,], or dutasteride [Avodart®) within 28 days prior to randomization are not eligible. The use of these drugs is not allowed during the patients' study participation.
  5. Patients with a history of non-cutaneous malignancy in the previous 5 years are not eligible.
  6. Patients taking warfarin, heparin, Aspirin >81mg/day, or other prescribed blood thinners: Reishi may increase the risk of bleeding.
  7. Patients with platelets levels below 139 X 103/ul or history of bleeding disorders
  8. Patients undergoing chemotherapy: Reishi may make some chemotherapy drugs less effective.
  9. Patients with any known immune disorder, including but not limited to HIV or other primary or secondary immune deficiency diseases, autoimmune diseases, history of or being considered for organ transplants, etc.
  10. Patients taking immunosuppressants (Corticosteroids, Calcineurin inhibitors, mTOR inhibitors, IMDH inhibitors, Biologics, Monoclonal antibodies): Reishi can stimulate immune responses.
  11. Patients taking cytochrome P450 2E1, 1A2, and 3A sensitive substrate drugs: Reishi may increase the risk of side effects of these drugs.
  12. Patient has total bilirubin >1.5 MG/DL, alanine aminotransferase (ALT) >51 U/L or aspartate aminotransferase (AST) >46 U/L.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mikei Red Reishi Essence EX
There are two groups (50 participants total) in this clinical study, one group (35 participants) will be given Mikei® Red Reishi Essence EX product (Product Group).
Dietary supplement: Mikei Red Reishi Essence EX
Dosage is 490 mg per capsule, 3 capsules twice a day with food or water. Total of 6 capsules per day.
Other Names:
  • Ganoderma lucidum (fruiting body) extract
  • lingzhi
Placebo Comparator: Placebo
Another group (15 participants) will be given the placebo (Placebo Group). Placebo is a pill that looks like a drug but has no drug or other active ingredients.
Dietary supplement: Placebo
Matching placebo. Consume 3 capsules twice a day with food or water. Total of 6 capsules per day.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in the immune function of the prostate cancer patients and patients with non-cancerous prostate conditions by taking reishi extract product. The immune function will be analyzed using D2Dx test by measuring the relative IgG level in the blood.
Time Frame: 6 months
D2Dx test is a two-step blood test that can measure the amount of IgG antibody adsorbed to a gold nanoparticle. Using a goat anti-human IgG antibody, the relative amount of IgG against autoantibodies is detected.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Correlation between the immune function as expressed in the IgG level in the blood and the disease status (determined by PSA, DRE changes, and Gleason score) of prostate cancer patients.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nikkei (Canada) Marketing Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Inoel Rivera, MD, Orlando Health Medical Group Urology
  • Principal Investigator: Qun Huo, Ph.D., University of Central Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RM5160

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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