Actively Recruiting
Effects of White Button Mushroom on Inflammation in Obese Postmenopausal Women at High Risk of Breast Cancer
Led by City of Hope Medical Center · Updated on 2026-01-05
26
Participants Needed
1
Research Sites
285 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial studies the effects of dietary white button mushroom on inflammation (the body's process of fighting against harmful things) and immune cells (white blood cells) in postmenopausal women with both high body mass index or BMI (percentage of body fat) and high risk of breast cancer. The body is in a constant state of alert when inflammation lingers at a low level and becomes chronic, as with having button mushroom is a dietary supplement that may improving responses of immune cells (white blood cells) and decreasing chronic inflammation. Information gathered from this study may help researchers determine whether white button mushroom have any effects on body fat and breast cancer risk.
CONDITIONS
Official Title
Effects of White Button Mushroom on Inflammation in Obese Postmenopausal Women at High Risk of Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenopausal women with high breast cancer risk and body mass index (BMI) of 30 or higher (25 or higher if Asian)
- Relative risk of breast cancer at least twice that of general population based on genetics, family history, or biopsy history
- Genetic mutation linked to hereditary breast cancer or certain family breast cancer patterns
- Prior biopsy showing atypical hyperplasia or carcinoma in situ within last 10 years
- High Gail Risk Assessment score (5-year risk of 1.7 or higher)
- Prior diagnosis of early breast cancer (T1 or T2) at least 5 years ago with no recent antiestrogen therapy
- Postmenopausal status confirmed by absence of menstruation for 12+ months, bilateral oophorectomy, or hysterectomy with menopausal hormone levels
- Bilateral mammogram within past 12 months not suspicious for breast cancer or documented continuous absence of disease after bilateral mastectomy for 5 years
- Normal kidney and liver function tests within specified limits
- Adequate blood counts (hemoglobin, platelets, white blood cells, neutrophils)
- Willingness to have blood drawn at start and 3 months
- Ability to swallow pills
- Age 21 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Awareness of breast cancer risk and willingness to provide informed consent
- Completed prior therapies at least 6 months before study entry
- No use of mushroom-containing supplements within 3 months before entry
You will not qualify if you...
- Active cancer within past 5 years except non-melanoma skin cancer or cervical carcinoma in situ
- Ongoing chemotherapy, radiation, or cancer treatment
- History of bleeding disorders or current use of blood thinners like Coumadin
- Recent use of hormone-modifying medications including systemic hormone replacement, SERMs, aromatase inhibitors, or GnRH modifiers within 3 months
- Current use of immunosuppressant drugs
- Uncontrolled illnesses such as active infection, heart failure, unstable angina, arrhythmia, hypertension, or psychiatric/social issues limiting study compliance
- Recent use of herbal or dietary mushroom supplements within 3 months
- Treatment with other investigational drugs
- Premenopausal status
- Known allergy to white button mushroom or similar compounds
- Regular use of high dose aspirin (325 mg or more daily) or NSAIDs
- Any condition that would make participation unsafe or limit ability to comply with study requirements according to the investigator's judgment
- Inability to comply with safety monitoring requirements of the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here