Mushrooms may fight inflammation in women at high breast cancer risk
NCT ID NCT04913064
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether eating white button mushrooms can lower inflammation and improve immune function in obese postmenopausal women who have a high risk of breast cancer. Researchers will measure changes in immune cells and inflammatory markers in the blood. The goal is to learn if mushrooms might help reduce breast cancer risk.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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City of Hope Medical Center
RECRUITINGDuarte, California, 91010, United States
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