White Button Mushroom for Inflammation in Obese Postmenopausal Women at High Risk of Breast Cancer
This study is looking at how white button mushroom extract affects inflammation (your body's way of fighting harmful things) and immune cells in postmenopausal women. To join, you must be a woman aged 21 or older, have a high body mass index (BMI of 30 or more), and be at least twice as likely to develop breast cancer as other women your age, possibly due to a known genetic mutation like BRCA1 or BRCA2. Researchers want to see if the mushroom extract can change levels of certain immune cells called myeloid-derived suppressor cells (MDSCs) and other immune cell types in your blood. The study is currently unclear about its status and plans to enroll 26 participants.
- Study design
- This is an interventional study planning to enroll 26 women. It is not specified if it is randomized or blinded.
- What's involved
- Participants will take white button mushroom extract by mouth daily for 3 months. You will also complete questionnaires.
- Compensation
- Not stated in the trial record.
- Follow-up
- Changes in immune cells will be measured from baseline up to 3 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04913064
Effects of White Button Mushroom on Inflammation in Obese Postmenopausal Women at High Risk of Breast Cancer
Recruiting
NAAges 21+InterventionalPreventionCity of Hope Medical CenterInvestigator-initiated
~26 participants
Updated 2026-01-05 on ClinicalTrials.gov
What's tested:Questionnaire AdministrationWhite Button Mushroom Extract
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relative change in levels of circulating myeloid-derived suppressor cells (MDSCs) within the peripheral blood mononuclear (PBMC) compartment
Measured over Baseline up to 3 months
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Lisa D Yee · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Relative change in levels of circulating myeloid-derived suppressor cells (MDSCs) within the peripheral blood mononuclear (PBMC) compartmentBaseline up to 3 months
Will assess relative change in % of MDSCs of PBMCs.
- Relative change in immune cell composition within the peripheral blood mononuclear (PBMC) compartmentBaseline up to 3 months
Will assess relative change in % of mononuclear cells of PBMCs