Turkey Tail Mushroom for Breast Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Medicinal mushrooms, Chemotherapy, Endocrine therapy

Disqualifiers: Advanced cancer, Immunocompromised, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3-6 weeks

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you are not currently taking any medicinal mushrooms, chemotherapy, or certain hormone therapies like aromatase inhibitors or selective estrogen receptor modifiers. If you are on these medications, you would need to stop them to participate.

Is Turkey Tail Mushroom safe for human use?

Turkey Tail Mushroom, also known as Coriolus Versicolor or Trametes Versicolor, has been used in traditional medicine for a long time and is generally considered safe. Studies have shown that its extracts, like PSK and PSP, are used in cancer treatment in Japan and China and have been found to improve quality of life and survival without significant safety concerns. ^{1 2 3 4 5}

How does the Turkey Tail Mushroom treatment differ from other breast cancer treatments?

Turkey Tail Mushroom treatment, using Coriolus Versicolor Extract, is unique because it primarily works by boosting the immune system and inhibiting tumor growth, rather than directly killing cancer cells. This treatment is derived from a medicinal mushroom and is known for its polysaccharides, which have shown immunomodulatory effects, making it different from conventional chemotherapy that targets cancer cells directly. ^{1 4 6 7 8}

What is the purpose of this trial?

This phase II trial tests how well turkey tail mushroom (TTM) works in treating post-menopausal women with HER2-negative, estrogen receptor (ER)-positive breast cancer undergoing surgery. TTM is a common mushroom. In traditional Chinese medicine, it is used for enhancing function and removing toxins, as well as for cancer, hepatitis, and infections. There is previous evidence of significant tumor shrinkage occurring in the 2-month window between diagnosis and surgery in women who have taken TTM. Giving TTM may be effective in treating post-menopausal women with HER2-negative, ER-positive breast cancer undergoing surgery.

Research Team

Larry R. Bergstrom, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for post-menopausal women with a specific breast cancer type: HER2-negative and ER-positive. They should be scheduled for surgery to treat their cancer. The eligibility criteria are not fully listed, but typically include factors like general health status and no conflicting conditions.

Inclusion Criteria

I am able to care for myself and perform daily activities.

I am not currently taking any aromatase inhibitors or estrogen blockers.

I am a woman aged 18 or older.

Exclusion Criteria

I am currently using medicinal mushrooms.

Allergy to mushrooms

Immunocompromised patients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive turkey tail mushroom (TTM) orally once or twice daily starting at the time of study registration and continuing up to the day prior to standard of care surgery

3-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-4 weeks

Treatment Details

Interventions

• Coriolus Versicolor Extract

Trial Overview The trial is testing the effects of Turkey Tail Mushroom (TTM) extract on shrinking tumors in patients before they undergo surgery. It's based on traditional uses and some evidence suggesting it might help reduce tumor size within two months prior to surgical intervention.

Participant Groups

Group I: Treatment (TTM) Experimental Treatment 2 Interventions

Patients receive TTM PO BID starting at the time of study registration and continuing up to the day prior to SOC surgery (up to 3-6 weeks) in the absence of disease progression or unacceptable toxicity.

Coriolus Versicolor Extract is already approved in Japan for the following indications:

Approved in Japan as Kawaratake for:

• Adjuvant cancer treatment

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

Coriolus versicolor, also known as Trametes versicolor, contains polysaccharides like PSP and PSK, which are being studied as potential adjuvant therapies for cancer, showing direct cytotoxic effects on cancer cells and stimulating the immune system.

Research indicates that these polysaccharides have varying levels of activity against different types of cancers, with evidence gathered from in vitro studies, animal models, and clinical outcomes, highlighting their potential role in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trametes versicolor (Synn. Coriolus versicolor) Polysaccharides in Cancer Therapy: Targets and Efficacy. Habtemariam, S.[2020]

Polysaccharopeptide (PSP), derived from the medicinal mushroom Coriolus versicolor, has been used in clinical practice in Japan and China for decades and shows promise in improving survival and quality of life for cancer patients and those with chronic diseases.

PSP works by activating immune cells and enhancing the production of important cytokines, which helps improve immune response against tumors and reduce side effects from conventional cancer treatments like chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical and clinical studies of Coriolus versicolor polysaccharopeptide as an immunotherapeutic in China. Chang, Y., Zhang, M., Jiang, Y., et al.[2022]

In a double-blind, placebo-controlled study of 34 patients with advanced non-small cell lung cancer (NSCLC), polysaccharide peptides (PSP) showed significant improvements in immune markers like blood leukocyte and neutrophil counts, as well as serum IgG and IgM levels after 28 days of treatment.

Patients receiving PSP experienced slower disease progression, with fewer withdrawals due to disease worsening compared to the control group, and no adverse reactions were reported, suggesting PSP may be a safe adjunct treatment for advanced NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coriolus versicolor polysaccharide peptide slows progression of advanced non-small cell lung cancer. Tsang, KW., Lam, CL., Yan, C., et al.[2022]

The mushroom Coriolus versicolor enhances the immune response by activating T-cells and macrophages, as shown in both in vitro and in vivo studies with mice.

Preparations from the mushroom did not show any direct cytotoxic effects on certain cancer cells, indicating a focus on immune activation rather than direct cell killing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polysaccharide-peptide complexes from the cultured mycelia of the mushroom Coriolus versicolor and their culture medium activate mouse lymphocytes and macrophages. Wang, HX., NG, TB., Liu, WK., et al.[2019]

A protein-bound polysaccharide (PSK) from Coriolus versicolor significantly prolonged the survival of Sprague-Dawley rats with mammary gland tumors, when administered at 250 mg/kg twice a week for 3 weeks after tumors reached a size of 100 mm².

The study indicates that PSK is effective during the growth stage of tumors, suggesting its potential as a therapeutic agent in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolongation of the survival period with the biological response modifier PSK in rats bearing N-methyl-N-nitrosourea-induced mammary gland tumors. Fujii, T., Saito, K., Matsunaga, K., et al.[2017]

Two polysaccharides, CVPn and CVPa, were isolated from the medicinal mushroom Coriolus versicolor, with CVPa showing a higher molecular weight and less branching than CVPn.

CVPa significantly enhanced immune responses in macrophage cells, including increased nitric oxide production and higher expression of immune-related genes, indicating that its structure contributes to its stronger immunomodulatory effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolation and structure elucidation of polysaccharides from fruiting bodies of mushroom Coriolus versicolor and evaluation of their immunomodulatory effects. Zhang, X., Cai, Z., Mao, H., et al.[2021]

Coriolus versicolor (CV) aqueous extract significantly inhibited cell migration and invasion in mouse mammary carcinoma cells without affecting cell proliferation, suggesting its potential as an anti-metastatic agent.

In a mouse model, daily oral administration of CV extract reduced tumor weight by 36% and lung metastasis by 70.8%, while also enhancing immune responses and protecting against breast cancer-induced bone destruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo and in vitro anti-tumor and anti-metastasis effects of Coriolus versicolor aqueous extract on mouse mammary 4T1 carcinoma. Luo, KW., Yue, GG., Ko, CH., et al.[2014]

The mycelium of Trametes versicolor (Turkey Tail mushroom) showed strong immune-activating properties, significantly inducing the CD69 activation marker on lymphocytes and monocytes, while the fermented substrate had only minor effects.

Both the mycelium and the metabolically fermented substrate contributed to immune activation, with the mycelium being more effective in triggering pro-inflammatory and anti-inflammatory cytokines compared to the initial substrate, highlighting the importance of both components in enhancing immune response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The mycelium of the Trametes versicolor (Turkey tail) mushroom and its fermented substrate each show potent and complementary immune activating properties in vitro. Benson, KF., Stamets, P., Davis, R., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Trametes versicolor (Synn. Coriolus versicolor) Polysaccharides in Cancer Therapy: Targets and Efficacy. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Preclinical and clinical studies of Coriolus versicolor polysaccharopeptide as an immunotherapeutic in China. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Coriolus versicolor polysaccharide peptide slows progression of advanced non-small cell lung cancer. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Polysaccharide-peptide complexes from the cultured mycelia of the mushroom Coriolus versicolor and their culture medium activate mouse lymphocytes and macrophages. [2019]

5. Greece pubmed.ncbi.nlm.nih.gov

Prolongation of the survival period with the biological response modifier PSK in rats bearing N-methyl-N-nitrosourea-induced mammary gland tumors. [2017]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Isolation and structure elucidation of polysaccharides from fruiting bodies of mushroom Coriolus versicolor and evaluation of their immunomodulatory effects. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

In vivo and in vitro anti-tumor and anti-metastasis effects of Coriolus versicolor aqueous extract on mouse mammary 4T1 carcinoma. [2014]

8. England pubmed.ncbi.nlm.nih.gov

The mycelium of the Trametes versicolor (Turkey tail) mushroom and its fermented substrate each show potent and complementary immune activating properties in vitro. [2023]