Overview

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

Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
Female
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
City of Hope Medical Center
Collaborator:
National Cancer Institute (NCI)
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

- 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 30 ml of blood (approximately 6 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