White Button Mushroom Extract for Breast Cancer Risk Reduction

Age: 18+

Sex: Female

Trial Phase: Academic

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether white button mushroom extract can reduce inflammation and improve immune cell activity in postmenopausal women at high risk for breast cancer. Researchers aim to determine if this dietary supplement can lower breast cancer risk in women with a high body mass index (BMI), which indicates higher body fat. Ideal participants are postmenopausal women with a BMI of 30 or higher who have at least twice the risk of developing breast cancer due to genetic factors or family history. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new preventive strategies for breast cancer.

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 prior data suggests that white button mushroom extract is safe for postmenopausal women with high BMI and breast cancer risk?

Research shows that white button mushrooms might help fight cancer. Studies have found that these mushrooms can slow the growth of breast cancer cells in lab tests, suggesting they could be safe and helpful in reducing cancer risk.

Other research has also demonstrated that mushrooms like these have anti-cancer effects in lab and animal studies. However, there is limited information about side effects in humans. So far, no strong evidence indicates that eating these mushrooms is harmful.

While this trial doesn't have a specific phase, testing a dietary supplement usually suggests it's relatively safe. White button mushrooms are commonly eaten and are generally considered safe in normal amounts. Participants will take the mushroom extract daily for three months, provided they do not experience any serious issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for breast cancer risk reduction, which often involve hormonal therapies or lifestyle changes, white button mushroom extract offers a natural and potentially less invasive option. Researchers are excited about this treatment because it harnesses the unique properties of white button mushrooms, which are thought to have anti-cancer effects through immune modulation and inhibition of aromatase, an enzyme involved in estrogen production. This approach could provide an alternative for those looking for preventative measures with fewer side effects than conventional therapies.

What evidence suggests that white button mushroom extract might be effective for reducing breast cancer risk?

Research has shown that white button mushrooms might help lower the risk of breast cancer. They contain substances that reduce the activity of aromatase, an enzyme linked to breast cancer growth. One study found that eating more mushrooms is linked to a lower risk of cancer in general. Additionally, white button mushrooms boost the immune system, which might help prevent cancer. In this trial, participants will receive white button mushroom extract to test its potential to improve health in women at high risk of breast cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Lisa D Yee

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• White Button Mushroom Extract

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.

How Is the Trial Designed?

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

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]

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]

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]

Edible and medicinal mushrooms have demonstrated significant anticancer effects against breast cancer cells, with various bioactive compounds contributing to these effects, as reviewed in multiple studies.

The article highlights a potential link between dietary consumption of these mushrooms and reduced breast cancer risk, supported by clinical studies and meta-analyses on the effects of fungal extracts in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-Cancer Potential of Edible/Medicinal Mushrooms in Breast Cancer. Gariboldi, MB., Marras, E., Ferrario, N., et al.[2023]

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]

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 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]

Citations

1. jn.nutrition.org jn.nutrition.org/article/S0022-3166(22)14440-8/fulltext

White Button Mushroom Phytochemicals Inhibit Aromatase ... The data from our study suggest that the white button mushroom may have potential therapeutic benefit as a functional food by reducing the activity of aromatase ...

2. meetings.asco.org meetings.asco.org/abstracts-presentations/62610

Abstract Because immunologic effects have been reported with medicinal mushrooms, cytokines were also measured. Results: WBM extract up to 13g per day was well tolerated ...

3. withpower.com withpower.com/trial/phase-breast-neoplasms-6-2021-c738e

White Button Mushroom Extract for Breast Cancer Risk ... 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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8483951/

Higher Mushroom Consumption Is Associated with Lower Risk ... A dose-response meta-analysis indicated that higher mushroom consumption of 18 g/d was associated with a 45% lower risk of total cancer than an ...

5. aacrjournals.org aacrjournals.org/cancerres/article/65/9_Supplement/1224/524089/Breast-cancer-prevention-with-phytochemicals-in

Breast cancer prevention with phytochemicals in mushrooms White button mushrooms (species Agaricus bisporus) are thought to be a useful chemopreventive agent for breast cancer, given that it suppresses aromatase/ ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10299416/

Anti-Cancer Potential of Edible/Medicinal Mushrooms in ... Edible/medicinal mushrooms have been shown to exert in vitro and in vivo anticancer effects on several kinds of tumors, including breast cancer.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955286320306124

White button mushroom (Agaricus bisporus) disrupts ... The present study revealed the mechanism that WBM extract interrupts AR activity, consequently leading to inhibit DHT-induced AR translocation, prevent co- ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8542389/

White Button Mushroom (Agaricus bisporus) Disrupts ... The information gained from this study improves the overall understanding of how WBM may contribute to the prevention and treatment of PCa.