What side effects are associated with this type of intervention?

Common treatments for breast cancer include chemotherapy, radiation therapy, hormone therapy, and targeted therapy. Chemotherapy can cause side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infections due to lowered white blood cell counts. Radiation therapy may lead to skin irritation, fatigue, and localized inflammation. Hormone therapy can result in hot flashes, mood swings, and an increased risk of blood clots. Targeted therapy often causes fewer side effects but can still lead to issues like diarrhea, liver problems, and skin rashes. These treatments can impact the immune system and cause inflammatory responses, which are areas of interest in the study of White Button Mushroom for its potential anti-inflammatory and immunomodulatory effects.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of breast cancer, particularly for cases that are advanced or metastatic. Pembrolizumab (Keytruda) is an anti-PD-1 therapy approved for triple-negative breast cancer with PD-L1 expression. Atezolizumab (Tecentriq), another immune checkpoint inhibitor targeting PD-L1, is approved in combination with nab-paclitaxel for PD-L1-positive, triple-negative breast cancer. These treatments work by modulating the immune system to target cancer cells, similar to the immunomodulatory effects being studied with white button mushrooms.

What other types of research exist?

Promising alternatives to White Button Mushroom for breast cancer patients include green tea polyphenols, which have shown anti-inflammatory and immunomodulatory effects, and Traditional Chinese Medicine (TCM) herbs, which are gaining interest for their reported effectiveness and safety profile. Additionally, ongoing research into the use of probiotics and dietary fiber to influence the gut microbiome and enhance immune response in cancer patients may offer novel therapeutic options.

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White Button Mushroom Extract for Breast Cancer Risk Reduction

N/A

Recruiting

Led By Lisa D Yee

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a known genetic mutation associated with hereditary breast cancer (including BRCA1, BRCA2, p53, etc.)

Two or more second degree relatives with breast cancer, with at least one under the age of 50

Must not have

History of a bleeding tendency or current use of Coumadin or other anticoagulants

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed for white button mushroom extract in this context, potential risks may include allergic reactions or digestive issues given its nature as a dietary supplement. Participants with known sensitivities to similar compounds are excluded from the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a genetic mutation linked to breast cancer.

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Two or more of my relatives have had breast cancer, with one being younger than 50.

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I am postmenopausal.

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I am a postmenopausal woman with a BMI of 30 or higher and at high risk for breast cancer.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My risk of developing breast cancer is high based on the Gail Risk Assessment.

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I had a biopsy showing early breast changes in the last 10 years.

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I have a family member with breast cancer diagnosed before 60.

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I can swallow pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I haven't taken hormone-modifying meds like HRT, SERMs, AIs, or GnRH modifiers in the last 3 months.

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I am currently receiving treatment for cancer.

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I haven't taken any mushroom supplements in the last 3 months.

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I regularly take full dose aspirin or NSAIDs.

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I have not gone through menopause.

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I am currently taking medication that suppresses my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relative change in immune cell composition within the peripheral blood mononuclear (PBMC) compartment

Relative change in levels of circulating myeloid-derived suppressor cells (MDSCs) within the peripheral blood mononuclear (PBMC) compartment

Secondary study objectives

Incidence of adverse events

Relative change in inflammatory cytokine gene expression in PBMC compartment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prevention (white button mushroom)Experimental Treatment2 Interventions

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

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include chemotherapy, hormone therapy, and immunotherapy, each with distinct mechanisms of action. Chemotherapy targets rapidly dividing cancer cells, causing cell death but also affecting normal cells, leading to side effects. Hormone therapy blocks hormones like estrogen that fuel certain breast cancers, slowing or stopping tumor growth. Immunotherapy enhances the body's immune response against cancer cells, often by targeting specific proteins that inhibit immune activity. These treatments are crucial for breast cancer patients as they aim to reduce tumor size, prevent metastasis, and improve survival rates. The anti-inflammatory and immunomodulatory effects, similar to those studied with White Button Mushroom, are particularly important as they can potentially reduce side effects and enhance the body's natural defenses against cancer.