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New treatment option for Breast Carcinoma
Official title Effects of White Button Mushroom on Inflammation in Obese Postmenopausal Women at High Risk of Breast Cancer
ClinicalTrials.gov ID: NCT04913064
What this study is testing
What is White Button Mushroom Extract?
White Button Mushroom Extract is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for breast carcinoma.
Also referred to as WBM Extract.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older, women only. Healthy volunteers may be eligible.
You may be able to join 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...
- 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
You likely can't join 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...
- 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...
- Concurrent use of immunosuppressant medications
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
See the full eligibility criteria
Who can 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
- 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...
- 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). people with a class IV mammogram may be entered once...
- 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 people 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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
- people 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
- people, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 21 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.