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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of turkey tail mushroom, a common mushroom in traditional medicine, in treating breast cancer in post-menopausal women. It specifically targets those with HER2-negative and estrogen receptor (ER)-positive breast cancer who are scheduled for surgery. The goal is to determine if turkey tail mushroom can shrink tumors before surgery. Eligible participants are post-menopausal, not currently on specific cancer drugs, and have a newly diagnosed, measurable breast cancer. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

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 there any evidence suggesting that turkey tail mushroom is likely to be safe for humans?

Research shows that turkey tail mushroom, also known as Coriolus versicolor, has been safely used in traditional medicine for many years, particularly in Japan and China. It contains compounds called PSP and PSK, which have been part of cancer treatments in these countries for over 30 years.

Studies have found that these mushrooms can help the immune system and may even slow the growth of cancer cells. Although detailed safety data for humans is limited, their long history of use and these findings suggest that turkey tail mushroom is generally safe.

This trial is in Phase 2, indicating that the treatment has already passed initial safety tests. This phase focuses more on the treatment's effectiveness, but safety remains closely monitored. Participants in this trial can feel reassured by the mushroom's long history of use and the research supporting its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Unlike the standard treatments for breast cancer, which often involve chemotherapy, radiation, or hormonal therapy, the new treatment uses an extract from the turkey tail mushroom, Coriolus Versicolor. This mushroom extract is known for its immune-boosting properties and offers a natural, less invasive approach. Researchers are excited about its potential to enhance the body's immune response against cancer cells, providing a complementary option to traditional therapies without the harsh side effects.

What evidence suggests that turkey tail mushroom might be an effective treatment for breast cancer?

Research has shown that turkey tail mushroom (TTM), which participants in this trial will receive, might help slow the growth of breast cancer cells. Studies have found that TTM extracts can have cancer-fighting effects, especially in hormone-sensitive breast cancer cells. Evidence indicates that tumors significantly shrank in women who took TTM between diagnosis and surgery. Additionally, TTM has proven safe and well-tolerated in women with breast cancer. This suggests that TTM could be helpful for treating post-menopausal women with HER2-negative, ER-positive breast cancer. ^{4 6 7 8 9}

Who Is on the Research Team?

Larry R. Bergstrom, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3369477/

Phase 1 Clinical Trial of Trametes versicolor in Women ... These findings show that up to 9 grams/day of a Tv preparation is safe and tolerable in women with breast cancer in the postprimary treatment setting.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00680667

Clinical Trial of Trametes Versicolor in Women With Breast ... Study Overview. RATIONALE: Coriolus versicolor mushroom extract may slow the growth of cancer cells and may be an effective treatment for breast cancer.

3. mdpi.com mdpi.com/1467-3045/47/10/808

Exploring the Anticancer Potential of Coriolus versicolor in ... Coriolus versicolor extracts have been shown to exert anticancer effects in hormone receptor-positive breast cancer cells, such as MCF-7, through multiple ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7277906/

Trametes versicolor (Synn. Coriolus ... versicolor was shown to be effective (100 mg/kg for 30 days) in suppressing sarcoma 180 tumours in mice [16]. Since then, the direct anticancer effect of C.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0753332223002123

The mycelium of the Trametes versicolor synn. Coriolus ... The mycelium of the Trametes versicolor synn. Coriolus versicolor (Turkey tail mushroom) exhibit anti-melanoma activity in vitro.

6. webmd.com webmd.com/vitamins/ai/ingredientmono-648/turkey-tail-mushroom

TURKEY TAIL MUSHROOM - Uses, Side Effects, and More Turkey tail (Coriolus versicolor) is a mushroom. It contains polysaccharide peptide (PSP) and polysaccharide krestin (PSK), which are used as medicine.

7. mskcc.org mskcc.org/cancer-care/integrative-medicine/herbs/coriolus-versicolor

Coriolus versicolor A Coriolus medicinal mushroom blend inhibited cell proliferation and induced G2/M cell cycle arrest in an invasive breast cancer cell line. The ...

8. cancer.gov cancer.gov/about-cancer/treatment/cam/hp/mushrooms-pdq

Medicinal Mushrooms (PDQ®)–Health Professional Version Medicinal mushrooms have been approved adjuncts to standard cancer treatments in Japan and China for more than 30 years and have an extensive clinical history ...

9. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Turkey_Tail_Mushrooms.pdf

Turkey Tail Mushrooms These studies suggest that Trametes versicolor may act as an immunostimulatory adjunct in the context of metastatic breast cancer, but it has not yet been.