Clinical Trials /

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

NCT03589781

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: RM5160
  • NCT ID: NCT03589781

Conditions

  • Prostate Cancer

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Mikei Red Reishi Essence EXExperimentalThere 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).
    PlaceboPlacebo ComparatorAnother 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.

      Eligibility Criteria

              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.
            
      Maximum Eligible Age:85 Years
      Minimum Eligible Age:50 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure: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
      Safety Issue:
      Description: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.

      Secondary Outcome Measures

      Measure: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
      Safety Issue:
      Description:

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Nikkei (Canada) Marketing Limited

      Last Updated

      November 19, 2019