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NCT03589781 | Withdrawn

• 1 other identifier: RM5160
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• 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.

  6 months

Study Arms (2)

Mikei Red Reishi Essence EX

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Mikei Red Reishi Essence EX DIETARY_SUPPLEMENT

Dosage is 490 mg per capsule, 3 capsules twice a day with food or water. Total of 6 capsules per day.

Also known as: Ganoderma lucidum (fruiting body) extract, lingzhi

Mikei Red Reishi Essence EX

Placebo DIETARY_SUPPLEMENT

Matching placebo. Consume 3 capsules twice a day with food or water. Total of 6 capsules per day.

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male age between 50-85
• 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
• Has not received any prostate cancer therapy including surgery, chemotherapy, hormone therapy, or radiation therapy
• 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)
• The clinical stage of the cancer is T1c or below (non-applicable for non-cancer patients with elevated PSA or high-grade PIN)
• The patients have been recommended for and placed under active surveillance without immediate treatment
• Able to provide written informed consent

You may not qualify if:

• Patients taking mushroom (including reishi) or other herbal products/natural supplements
• Patients with a known allergy to mushrooms
• Prisoners
• 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.
• Patients with a history of non-cutaneous malignancy in the previous 5 years are not eligible.
• Patients taking warfarin, heparin, Aspirin \>81mg/day, or other prescribed blood thinners: Reishi may increase the risk of bleeding.
• Patients with platelets levels below 139 X 103/ul or history of bleeding disorders
• Patients undergoing chemotherapy: Reishi may make some chemotherapy drugs less effective.
• 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.
• Patients taking immunosuppressants (Corticosteroids, Calcineurin inhibitors, mTOR inhibitors, IMDH inhibitors, Biologics, Monoclonal antibodies): Reishi can stimulate immune responses.
• Patients taking cytochrome P450 2E1, 1A2, and 3A sensitive substrate drugs: Reishi may increase the risk of side effects of these drugs.
• Patient has total bilirubin \>1.5 MG/DL, alanine aminotransferase (ALT) \>51 U/L or aspartate aminotransferase (AST) \>46 U/L.

Sponsors & Collaborators

• Nikkei (Canada) Marketing Limited: lead

Study Sites (1)

Orlando Health Medical Group Urology

Orlando, Florida, 32804, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Inoel Rivera, MD

  Orlando Health Medical Group Urology

  PRINCIPAL INVESTIGATOR

• Qun Huo, Ph.D.

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: July 18, 2018
• Study Start: November 5, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-03

Locations

US (1)