Effects of White Button Mushroom on Inflammation in Obese Postmenopausal Women at High Risk of Breast Cancer
White Button Mushroom and Biomarkers of Immune Cell and Inflammatory Responses in Obese Postmenopausal Women at High Risk of Breast Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 21 Years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 3 months
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "To evaluate effects of WBM on diet quality and composition (food frequency questionnaires, 24 hour recall, red blood cell fatty acid profiles)."
- "OUTLINE: Participants receive white button mushroom orally (PO) daily for 3 months in the absence of disease progression or unacceptable toxicity."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether white button mushroom powder pills affect long-term inflammation and white blood cells, which help fight illness. It is for women age 21 or older who have gone through menopause, have a high body mass index (BMI), and have a high risk of breast cancer. Researchers also want to learn about possible effects on body fat and breast cancer risk.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 21 or older and past menopause: no periods for at least 12 months, both ovaries removed, or the uterus removed with a blood test showing menopause.
- Have a BMI of at least 30, or at least 25 for Asian women. BMI is a measure based on height and weight.
- Have a breast cancer risk more than twice that of others your age. Listed risk factors include certain gene changes, family history, past abnormal breast tissue tests, a high risk score, or certain past breast cancers.
- Have a mammogram of both breasts within the past 12 months with no signs of cancer, or a biopsy showing no cancer after a suspicious result. If both breasts were removed, have records showing no cancer for 5 years.
- Meet the study's blood count, liver, and kidney test rules. Be fully active or able to do light work.
- Be able to swallow pills and agree to blood draws of about 8–10 teaspoons at the start and at 3 months.
- Understand your increased breast cancer risk and the study's possible benefits and harms, and agree to sign a consent form.
- Have finished prior cancer treatment or cancer-prevention treatment at least 6 months before joining.
Who can't join
- Have had active cancer within the past 5 years, except non-melanoma skin cancer or very early cancer of the cervix. Current chemotherapy, radiation, or other cancer treatment is not allowed.
- Have a history of bleeding problems or take blood thinners, such as Coumadin.
- Have used medicines that change hormone levels within 3 months of study group assignment, or currently take medicines that weaken the immune system. Local vaginal hormone treatments are allowed.
- Have an uncontrolled illness, such as an infection, heart problem, or high blood pressure, or a mental health or social problem that would prevent following study rules.
- Have regularly used mushroom supplements within the past 3 months, or are receiving another experimental treatment.
- Have not gone through menopause, are pregnant, or could become pregnant.
- Have a known allergy or sensitivity to white button mushrooms or similar substances, or regularly take aspirin at 325 mg a day or more or anti-inflammatory pain medicines called NSAIDs.
- Have another condition that the study doctor believes makes participation unsafe, or cannot follow the study's safety checks.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (1)
CA
- City of Hope Medical Center · Duarte, CA 91010Lisa D. Yee · Study contact · 626-471-7100 · lyee@coh.orgLisa D. Yee · Principal investigatorMore trials in Duarte