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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to substances similar to WBM.I have a history of bleeding easily or am currently using blood thinners.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 do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am a postmenopausal woman aged 21 or older.Your kidney function, measured by a blood test called serum creatinine, should be within a certain range.I was diagnosed with early-stage breast cancer over 5 years ago and have not used antiestrogen therapy for more than 6 months.Your liver enzyme levels are not too high.I am a postmenopausal woman with a BMI of 30 or higher and at high risk for breast cancer.Your platelet count is 100,000 or higher.I have a genetic mutation linked to breast cancer.Two or more of my relatives have had breast cancer, with one being younger than 50.I've had a biopsy showing early breast changes in the last 10 years.I haven't taken hormone-modifying meds like HRT, SERMs, AIs, or GnRH modifiers in the last 3 months.I am postmenopausal.I am a postmenopausal woman with a BMI of 30 or higher and at high risk for breast cancer.My risk of developing breast cancer is high based on the Gail model.I am fully active or restricted in physically strenuous activity but can do light work.I am currently receiving treatment for cancer.My risk of developing breast cancer is high based on the Gail Risk Assessment.My risk of developing breast cancer is more than twice that of others my age.I had a biopsy showing early breast changes in the last 10 years.I have a genetic mutation linked to breast cancer.I haven't taken any mushroom supplements in the last 3 months.I have a family member with breast cancer diagnosed before 60.Your total bilirubin level is within 1.5 times the normal limit.I am willing to give 8-10 teaspoons of blood for tests.I regularly take full dose aspirin or NSAIDs.I have two or more relatives who had breast cancer, one was younger than 50.You are very overweight, especially for people of Asian descent.I haven't had cancer in the last 5 years, except for non-dangerous skin cancer or early cervical cancer.You are currently using other experimental drugs.I have not gone through menopause.I was diagnosed with early-stage breast cancer over 5 years ago and have not used antiestrogen therapy for more than 6 months.I can swallow pills.I am currently taking medication that suppresses my immune system.My recent mammogram showed no signs of breast cancer, or I've been cancer-free for 5 years after a mastectomy.Your hemoglobin level is 9.0 grams per deciliter or higher.You need to have a certain level of a type of white blood cell called neutrophils.
Research Study Groups:
This trial has the following groups:- Group 1: Prevention (white button mushroom)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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