White Button Mushroom Extract for Breast Cancer Risk Reduction

Recruiting in Palo Alto (17 mi)

Overseen by Lisa D Yee

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: City of Hope Medical Center

Must not be taking: Anticoagulants, Hormone modifiers, Immunosuppressants, others

Disqualifiers: Active malignancy, Chemotherapy, Bleeding tendency, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing if eating white button mushrooms every day can help improve health in obese postmenopausal women at high risk of breast cancer. The mushrooms might help by making immune cells work better and reducing long-term inflammation. Researchers hope this could lower the risk of breast cancer and improve overall health.

Will I have to stop taking my current medications?

The trial requires that you stop using hormone-modifying medications, immunosuppressants, and certain herbal or dietary supplements containing mushrooms at least 3 months before joining. You also cannot be on full-dose aspirin, NSAIDs, or anticoagulants like Coumadin. If you're on any of these, you may need to stop them to participate.

What data supports the effectiveness of the treatment White Button Mushroom Extract for reducing breast cancer risk?

Research shows that white button mushrooms (Agaricus bisporus) have compounds that can help fight breast cancer by boosting the immune system and directly inhibiting cancer cell growth. Studies on rats and human cancer cells suggest these mushrooms may reduce tumor growth and have protective effects against breast cancer. ^{1 2 3 4 5}

Is White Button Mushroom Extract safe for humans?

Some studies in mice and rats have shown that consuming Agaricus bisporus (White Button Mushroom) can lead to tumor development in various organs, but these results are not consistent across all studies. One study in rats did not find a significant difference in tumor incidence between those fed the mushroom and those not, suggesting no clear evidence of carcinogenicity. However, these findings are based on animal studies, and more research is needed to determine safety in humans. ^{2 4 6 7 8}

How does white button mushroom extract differ from other breast cancer treatments?

White button mushroom extract is unique because it contains polysaccharides that can boost the immune system and inhibit breast cancer cell growth, offering a natural, dietary-based approach to cancer prevention and treatment, unlike traditional chemotherapy drugs. ^{2 3 4 5 9}

Research Team

Lisa D Yee

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for postmenopausal women with a high BMI (>=30 kg/m^2), at increased risk of breast cancer due to factors like genetic mutations (BRCA1/2, p53), family history, or previous diagnoses of certain breast conditions. Participants must be over 21 years old, have had no recent mushroom supplements, and not be on hormone therapies or other treatments that could interfere.

Inclusion Criteria

I finished any previous cancer treatments over 6 months ago and stopped taking mushroom supplements within the last 3 months.

Your total white blood cell count is less than 3500 per cubic millimeter.

I am a postmenopausal woman aged 21 or older.

Exclusion Criteria

You are allergic to substances similar to WBM.

I have a history of bleeding easily or am currently using blood thinners.

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive white button mushroom orally daily for 3 months

12 weeks

Regular visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• White Button Mushroom Extract (Cancer Vaccine)

Trial Overview Researchers are testing the effects of white button mushroom extract on inflammation and immune function in obese postmenopausal women at high risk for breast cancer. The study involves taking the supplement and monitoring changes through questionnaires and blood tests to see if it might reduce body fat or cancer risk.

Participant Groups

Group I: Prevention (white button mushroom) Experimental Treatment 2 Interventions

Participants receive white button mushroom PO daily for 3 months in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

Robert Stone

City of Hope Medical Center

Chief Executive Officer since 2014

Juris Doctorate from the University of Chicago, Bachelor's degree in Political Science from the University of Redlands

Sumanta (Monty) Pal

City of Hope Medical Center

Chief Medical Officer since 2023

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

In a study using a triple-negative breast cancer mouse model, an orally administered blend of medicinal mushrooms rich in β-glucans significantly reduced the density of cerebellar metastases by about 50%, indicating its potential as an effective anti-cancer treatment.

The medicinal mushroom blend not only inhibited metastasis but also regulated key genes involved in apoptosis and cell proliferation, suggesting it could be a promising adjuvant treatment alongside conventional therapies for managing brain metastases in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fighting secondary triple-negative breast cancer in cerebellum: A powerful aid from a medicinal mushrooms blend. De Luca, F., Roda, E., Ratto, D., et al.[2023]

The white button mushroom extract significantly improved antioxidant enzyme activity and reduced tumor biomarkers in rats with DMBA-induced breast cancer, suggesting its protective effects against cancer.

Rats treated with the mushroom extract showed better maintenance of red blood cell levels and improved lipid profiles compared to those treated with doxorubicin, indicating its potential as a safer alternative in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the therapeutic potential of white button mushroom (Agaricus bisporus) against DMBA-induced breast cancer in Sprague Dawley rats. Latif, A., Issa Khan, M., Rakha, A., et al.[2022]

Polysaccharides extracted from Agaricus bisporus (white button mushroom) have been shown to stimulate immune responses in murine macrophages, leading to increased production of important immune factors like nitric oxide and interleukin-6.

Both polysaccharide fractions (ABP-1 and ABP-2) inhibited the growth of human breast cancer cells (MCF-7) and reduced tumor growth in mice implanted with murine Sarcoma 180 cells, suggesting a potential antitumor effect linked to immune modulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macrophage immunomodulating and antitumor activities of polysaccharides isolated from Agaricus bisporus white button mushrooms. Jeong, SC., Koyyalamudi, SR., Jeong, YT., et al.[2016]

Three edible mushroom extracts (Coprinellus sp., Coprinus comatus, and Flammulina velutipes) were identified as potential anti-breast cancer agents, showing significant growth inhibition and induction of apoptosis in both estrogen-receptor positive (MCF-7) and negative (MDA-MB-231, BT-20) breast cancer cells.

The extracts demonstrated dose-dependent cytotoxicity, with particularly low IC50 values (as low as 30-40 microg/ml) for the estrogen-receptor negative cells, and effectively reduced tumor colony formation by up to 99%, highlighting their potential as novel treatments for malignant estrogen-independent breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro effects on proliferation, apoptosis and colony inhibition in ER-dependent and ER-independent human breast cancer cells by selected mushroom species. Gu, YH., Leonard, J.[2015]

A study on Swiss mice showed that continuous feeding of lyophilized Agaricus bisporus (AB) mushrooms led to the development of tumors in various organs, including the lungs and ovaries, indicating potential carcinogenic effects.

The tumors identified were classified as adenomas and adenocarcinomas, and while some tumor incidences were statistically significant, no clear dose-response relationship was found, raising concerns about the safety of consuming this mushroom in lyophilized form.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carcinogenesis studies with the lyophilized mushroom Agaricus bisporus in mice. Toth, B., Gannett, P., Visek, WJ., et al.[2007]

A study on Swiss mice showed that consuming uncooked Agaricus bisporus mushrooms led to significant tumor development, with incidences of 16% in bone and 62% in lungs for males, indicating potential carcinogenic effects.

The research demonstrated that tumors were classified as various types, including osteomas, squamous cell carcinomas, and adenocarcinomas, highlighting the serious health risks associated with the consumption of these mushrooms in their raw form.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer induction in mice by feeding of the uncooked cultivated mushroom of commerce Agaricus bisporus. Toth, B., Erickson, J.[2007]

In a study involving female Charles River Sprague-Dawley rats fed a diet containing 30% Agaricus bisporus for 500 days, no significant increase in tumor incidence was found compared to a control group, suggesting that this edible mushroom does not exhibit carcinogenic properties.

Despite the experimental group developing various tumors, the overall incidence was not significantly different from the control group, indicating that Agaricus bisporus is likely safe for consumption in terms of cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carcinogenicity examination of Agaricus bisporus, edible mushroom, in rats. Matsumoto, K., Ito, M., Yagyu, S., et al.[2019]

In a clinical phase I trial, white button mushroom (WBM) powder significantly reduced prostate-specific antigen (PSA) levels in patients with biochemically recurrent prostate cancer, suggesting its potential as a chemo-preventative and therapeutic agent.

WBM extract was shown to inhibit DHT-induced PSA expression and cell proliferation in prostate cancer cell lines, and it also suppressed tumor growth in patient-derived xenografts, indicating its mechanism of action involves disrupting androgen receptor signaling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

White button mushroom (Agaricus bisporus) disrupts androgen receptor signaling in human prostate cancer cells and patient-derived xenograft. Wang, X., Ha, D., Mori, H., et al.[2022]

References

1. France pubmed.ncbi.nlm.nih.gov

Fighting secondary triple-negative breast cancer in cerebellum: A powerful aid from a medicinal mushrooms blend. [2023]

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

Evaluating the therapeutic potential of white button mushroom (Agaricus bisporus) against DMBA-induced breast cancer in Sprague Dawley rats. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Anti-Cancer Potential of Edible/Medicinal Mushrooms in Breast Cancer. [2023]

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

Macrophage immunomodulating and antitumor activities of polysaccharides isolated from Agaricus bisporus white button mushrooms. [2016]

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

In vitro effects on proliferation, apoptosis and colony inhibition in ER-dependent and ER-independent human breast cancer cells by selected mushroom species. [2015]

6. Greece pubmed.ncbi.nlm.nih.gov

Carcinogenesis studies with the lyophilized mushroom Agaricus bisporus in mice. [2007]

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

Cancer induction in mice by feeding of the uncooked cultivated mushroom of commerce Agaricus bisporus. [2007]

8. Ireland pubmed.ncbi.nlm.nih.gov

Carcinogenicity examination of Agaricus bisporus, edible mushroom, in rats. [2019]

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

White button mushroom (Agaricus bisporus) disrupts androgen receptor signaling in human prostate cancer cells and patient-derived xenograft. [2022]