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Breast CarcinomaNCT04913064

Effects of White Button Mushroom on Inflammation in Obese Postmenopausal Women at High Risk of Breast Cancer

A study testing Questionnaire Administration and White Button Mushroom Extract in people with Breast Carcinoma, run by City of Hope Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Carcinoma
What is being tested?
Questionnaire Administration and White Button Mushroom Extract
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
27 Jul 2021to 12 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Lisa D. Yee, 626-471-7100, lyee@coh.org

    Lisa D. Yee

    Recruiting

Other trials in United States

About this study

Official title: White Button Mushroom and Biomarkers of Immune Cell and Inflammatory Responses in Obese Postmenopausal Women at High Risk of Breast Cancer

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine effects of white button mushroom (WBM) on circulating immune cell profiles, and specifically myeloid-derived suppressor cells (MDSCs), in obese (BMI >= 30 kg/m^2, Asian BMI >= 25 kg/m^2) postmenopausal women at high risk of breast cancer.

SECONDARY OBJECTIVES:

  1. To evaluate changes in circulating biomarkers of inflammation. II. To evaluate changes in immune cell profiles and inflammation in breast adipose tissue samples.

III. To evaluate tolerability of WBM in a study cohort of obese postmenopausal women.

IV. To evaluate changes in BMI, central adiposity (waist circumference), and metabolic health (glucose, insulin, lipid panel, alanine aminotransferase [ALT], aspartate aminotransferase [AST]).

  1. 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.

Being tested
Questionnaire Administration, White Button Mushroom Extract
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Questionnaire AdministrationOther

    Ancillary studies

  • White Button Mushroom ExtractDrug

    Also called WBM Extract

    Given PO

Study groups in NCT04913064
Study groupRoleWhat they receive
Prevention (white button mushroom)ExperimentalParticipants receive white button mushroom PO daily for 3 months in the absence of disease progression or unacceptable toxicity.
Receives: Other: Questionnaire Administration; Drug: White Button Mushroom Extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative change in levels of circulating myeloid-derived suppressor cells (MDSCs) within the peripheral blood mononuclear (PBMC) compartment

    Will assess relative change in % of MDSCs of PBMCs.

    Measured: Baseline up to 3 months

  2. Relative change in immune cell composition within the peripheral blood mononuclear (PBMC) compartment

    Will assess relative change in % of mononuclear cells of PBMCs

    Measured: Baseline up to 3 months

Secondary outcomes (2)

  1. Relative change in inflammatory cytokine gene expression in PBMC compartment

    Will assess relative change in % cytokine gene expression

    Measured: Baseline up to 3 months

  2. Incidence of adverse events

    Toxicity will be defined per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version. 5.0.

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2021
  2. Study start27 Jul 2021
  3. Primary completion12 Jan 2027 (estimated)
  4. Study completion12 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04913064
Sponsor's protocol ID
20171
Other IDs
NCI-2021-02148, 20171, P30CA033572
Status last verified
Dec 2025
First submitted
20 Apr 2021
Last updated
5 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Questionnaire Administration and White Button Mushroom Extract in people with Breast Carcinoma, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative change in levels of circulating myeloid-derived suppressor cells (MDSCs) within the peripheral blood mononuclear (PBMC) compartment (time frame: Baseline up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04913064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.

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