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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
Prior therapies, including chemoprevention or adjuvant therapies, must have been completed for 6 or more months prior to study entry. Prior use of mushroom or mushroom chemical-containing supplements must have been completed within 3 months of study entry
This study will assess WBM powder in postmenopausal women of 21 years of age or older. Younger women are unlikely to be postmenopausal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights

Study Summary

This trial looks at the effects of white button mushrooms on inflammation and immune cells in postmenopausal women who are overweight and at high risk for breast cancer.

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.Check my eligibility
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.See study design
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 finished any previous cancer treatments over 6 months ago and stopped taking mushroom supplements within the last 3 months.
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I am a postmenopausal woman aged 21 or older.
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I was diagnosed with early-stage breast cancer over 5 years ago and have not used antiestrogen therapy for more than 6 months.
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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 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've had a biopsy showing early breast changes in the last 10 years.
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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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My risk of developing breast cancer is high based on the Gail model.
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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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My risk of developing breast cancer is more than twice that of others my age.
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I had a biopsy showing early breast changes in the last 10 years.
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I have a genetic mutation linked to breast cancer.
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I have a family member with breast cancer diagnosed before 60.
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I am willing to give 8-10 teaspoons of blood for tests.
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I have two or more relatives who had breast cancer, one was younger than 50.
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I can swallow pills.
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My recent mammogram showed no signs of breast cancer, or I've been cancer-free for 5 years after a mastectomy.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Incidence of adverse events
Relative change in inflammatory cytokine gene expression in PBMC compartment

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.

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
561 Previous Clinical Trials
1,918,226 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,369 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,343 Patients Enrolled for Breast Cancer
Lisa D YeePrincipal InvestigatorCity of Hope Medical Center

Media Library

White Button Mushroom Extract Clinical Trial Eligibility Overview. Trial Name: NCT04913064 — N/A
Breast Cancer Research Study Groups: Prevention (white button mushroom)
Breast Cancer Clinical Trial 2023: White Button Mushroom Extract Highlights & Side Effects. Trial Name: NCT04913064 — N/A
White Button Mushroom Extract 2023 Treatment Timeline for Medical Study. Trial Name: NCT04913064 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are accepted into the experiment?

"Affirmative. The clinicaltrials.gov database suggests that the trial is currently recruiting patients, with initial posting on July 27th 2021 and most recent update occurring March 9th 2022. There are 26 individuals sought from a single medical centre."

Answered by AI

Is there an opportunity to join the trial at this time?

"Affirmative. Data hosted on clinicaltrials.gov substantiates that this medical trial, first posted in July 2021, is actively seeking enrollees. Approximately 26 participants need to be recruited from 1 site."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
City of Hope Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby Jul 2024