Effects of white button mushroom on inflammation in obese postmenopausal women at high risk of breast cancer
Official title: White Button Mushroom and Biomarkers of Immune Cell and Inflammatory Responses in Obese Postmenopausal Women at High Risk of Breast Cancer
Run by City of Hope Medical Center · NCT04913064 · Data updated 2026-11-12
This study is testing if eating white button mushrooms every day for three months can help reduce inflammation and improve immune health in obese postmenopausal women who are at high risk for breast cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | Women only |
| Enrollment | 26 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Duarte, California) |
| Status | Recruiting |
| Started | July 27, 2021 |
| Main results expected | January 12, 2027 |
| Study ends | January 12, 2027 |
| Registry record updated | January 5, 2026 |
| Trial ID | NCT04913064 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are postmenopausal women with a BMI of 30 kg/m² or higher and a significantly increased risk of breast cancer.
✕Probably not a fit
Patients who are not postmenopausal or do not meet the obesity and breast cancer risk criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates how dietary white button mushroom affects inflammation and immune cell profiles in obese postmenopausal women who are at high risk for breast cancer. Participants will consume white button mushroom daily for three months, and researchers will assess changes in immune cells, inflammation biomarkers, and metabolic health. The study aims to determine if this dietary intervention can improve immune responses and reduce chronic inflammation, potentially lowering breast cancer risk.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary approach to reduce inflammation and breast cancer risk in high-risk populations.
How similar studies have gone: While dietary interventions for cancer prevention are being explored, the specific use of white button mushroom in this context is relatively novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * This study will be conducted in postmenopausal women who have increased risk of breast cancer and high BMI \>= 30 kg/m\^2 * The study population will consist of women with a relative risk of developing breast cancer that is at least \> 2 x that of the general population for their age group based on any of the following: * Have a known genetic mutation associated with hereditary breast cancer (including BRCA1, BRCA2, p53, etc.) * One or more first degree relatives with breast cancer, with at least one under the age of 60 * Two or more second degree relatives with breast cancer, with at least one under the age of 50 * Prior biopsy diagnosing atypical lobular hyperplasia, atypical ductal hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ in the last 10 years * Have a Gail Risk Assessment (which is based on age, race, age of menarche, age of first live birth, number of first degree relatives with breast cancer, number of breast biopsies, and presence of high risk histology on any biopsies) that is considered high risk compared to the general population i.e. 5 year Gail \>= 1.7 * Prior diagnosis of T1 or T2 breast cancer \>= 5 years, without antiestrogen therapy for \> six months when applicable * ELIGIBILITY CRITERIA FOR HIGH RISK PATIENTS FOR THE CLINICAL TRIAL * Body mass index (BMI) \>= 30 (Asian BMI \>= 25 kg/m\^2) * Postmenopausal, defined as continuous absence of menstruation for 12+ months, status post bilateral oophorectomy, or status post hysterectomy with follicle stimulating hormone (FSH) in menopausal range * Bilateral mammogram within the 12 months prior to study enrollment that is read as not suspicious for breast cancer (American College of Radiology \[ACR\] class I-III). Subjects with a class IV mammogram may be entered once they have had a negative biopsy. In cases of bilateral mastectomy, documentation that the patient has been continuously without evidence of disease for 5 years will suffice * Serum creatinine of 1.5 X upper limit of institutional norm or less * Total bilirubin of 1.5 X upper limit of institutional norm or less * ALT and aspartate aminotransferase (AST) of less than 2 X upper limit of institutional norm or less * Hemoglobin of 9.0 gm/dL or more * Platelets of 100,000/mm\^3 or more * Total white blood cell (WBC) of 3500/mm\^3 * Absolute neutrophil count (ANC) of 1500/mm\^3 or more * Must be willing to have about 40-50 ml of blood (approximately 8-10 teaspoons) drawn at 0 and 3 months * Must be able to swallow pills * This study will assess WBM powder in postmenopausal women of 21 years of age or older. Younger women are unlikely to be postmenopausal * Participants will have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * The effects of WBM on the developing fetus are unknown. Pregnant and women with childbearing potential are not eligible to participate in this study of postmenopausal women at high risk of breast cancer * All subjects must have the ability to understand and the willingness to sign a written informed consent. Participants must be aware of their increased breast cancer risk and willingly consent after being informed of the investigational nature of the intervention, alternatives, potential benefits, side-effects, risks, and discomforts * 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 Exclusion Criteria: * Active malignancy within the past 5 years with the exception of non-melanoma skin cancer or carcinoma in situ of the cervix. NOTE: If there is a history of prior malignancy, the participant must not be receiving other specific treatment, i.e., other hormonal therapy, for their cancer * Ongoing chemotherapy, radiation therapy, or other cancer-related treatment * History of a bleeding tendency or current use of Coumadin or other anticoagulants * Concurrent use of hormone-modifying medications including systemic hormone replacement therapy (local vaginal preparations are permitted), selective estrogen receptor modifiers (SERMs), aromatase inhibitors (Ais), or gonadotropic-releasing hormone (GnRH) modifiers within 3 months of randomization * Concurrent use of immunosuppressant medications * 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 * Chronic use of any herbal or dietary supplement containing mushrooms within the 3 months prior to entry on the study * Treatment with other investigational agents * Premenopausal status * Known sensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to WBM or * Subjects on a standing regimen of full dose aspirin (\>= 325 mg/day), nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID-containing products * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Where it's running
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City of Hope Medical Center
Duarte, California, United States Recruiting
Study contacts
- Principal investigator: Lisa D Yee — City of Hope Medical Center
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.