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

NCT04913064 | Recruiting DMC

• 3 other identifiers: 20171NCI-2021-02148P30CA033572
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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

Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline up to 3 months

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

  Will assess relative change in % of mononuclear cells of PBMCs

  Baseline up to 3 months

Secondary Outcomes (2)

• Relative change in inflammatory cytokine gene expression in PBMC compartment

  Baseline up to 3 months

• Incidence of adverse events

  Up to 3 months

Study Arms (1)

Prevention (white button mushroom)

EXPERIMENTAL

Participants receive white button mushroom PO daily for 3 months in the absence of disease progression or unacceptable toxicity.

Other: Questionnaire Administration; Drug: White Button Mushroom Extract

Interventions

Questionnaire Administration OTHER

Ancillary studies

Prevention (white button mushroom)

White Button Mushroom Extract DRUG

Given PO

Also known as: WBM Extract

Prevention (white button mushroom)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lisa D Yee

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: June 4, 2021
• Study Start: July 27, 2021
• Primary Completion (Estimated): January 12, 2027
• Study Completion (Estimated): January 12, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

US (1)