Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Carcinoma

Breast Neoplasms

Inflammation

Obesity

Breast Diseases

Skin Diseases

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

Questionnaire Administration

White Button Mushroom Extract

Lisa D. Yee

Lisa D Yee

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.

PRIMARY OBJECTIVE:

I. 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:

I. 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 \[AST\]).

V. 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.

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

Will assess relative change in % of MDSCs of PBMCs.

Will assess relative change in % of mononuclear cells of PBMCs

Will assess relative change in % cytokine gene expression

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

National Cancer Institute (NCI)

City of Hope Medical Center

Recurrence

Dose escalation with six evaluable subjects per dose level. Doses begin at 5 g/day, then 8 g/day, then 10 g/day then 13 g/day.

white button mushroom extract

Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.

flow cytometry

high performance liquid chromatography

Performed on blood samples taken pre-treatment on day 1 and on day 85 after treatment.

laboratory biomarker analysis

mass spectrometry

Performed on blood samples taken on days 1, 8, 15, 29, 57 and 85 of treatment.

pharmacogenomic studies

Performed on blood samples taken pre-dose and at 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours after White Button Mushroon extract on day 1 of treatment and pre-dose on days 8, 15, 29, 57 and 85 after start of treatment.

pharmacological study

Shiuan Chen, PhD

RATIONALE: White button mushroom extract may stop or delay the recurrence of breast cancer in postmenopausal breast cancer survivors.

PURPOSE: This phase I trial is studying the side effects and best dose of white button mushroom extract in preventing the recurrence of breast cancer in postmenopausal women who are breast cancer survivors.

OBJECTIVES:

Primary

* To show that a whole food extract of white button mushrooms (WBM) can inhibit aromatase-induced estrogen biosynthesis in postmenopausal women who are breast cancer survivors (BCS).
* To determine the optimal daily dose of WBM needed to induce aromatase inhibition of estrogen biosynthesis in these patients.
* To determine the bioavailability of C-18 unsaturated fatty acids, which are thought to moderate the anticancer effects of WBM.

Secondary

* To determine the safety and tolerability of WBM in humans via serial comprehensive symptom questionnaires, pre- and post-treatment markers of bone metabolism, and pre- and post-treatment comprehensive lipid panels.
* To explore potential alternate antitumor mechanisms, specifically the effect of WBM on cytokines as well as innate and adaptive cellular immunity.
* To describe barriers experienced in recruitment of ethnically diverse subjects from the community into a secondary prevention BCS trial utilizing a dietary supplement intervention in an effort to enhance feasibility of a subsequent phase II trial.

OUTLINE: This is a dose-escalation study.

Patients receive oral white button mushroom extract twice daily for 12 weeks in the absence of a second primary ductal carcinoma in situ, invasive breast cancer, or unacceptable toxicity.

Patients undergo blood and urine sample collection at baseline and periodically during treatment for pharmacokinetic, pharmacodynamic, and immunologic correlative studies. Blood and urine samples are analyzed for concentrations of C-18 unsaturated fatty acids (CUFA) by high-performance liquid chromatography tandem-mass spectrometry. Blood samples are also analyzed for anti-aromatase activity by ex vivo plasma aromatase inhibition assays; circulating sex steroid hormones by radioimmunoassay; serum immune cytokine levels by multiplex cytokine analyses; immunophenotyping, NK-cell activation status, and NK-cell function by multiparameter flow cytometry; lipid levels by lipid assays; and biochemical markers of bone metabolism by bone metabolism marker assays. DNA, RNA, and plasma samples are stored for post-trial pharmacogenomic studies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effects of White Button Mushroom on Inflammation in Obese Postmenopausal Women at High Risk of Breast Cancer	NCT04913064	Breast Carcinom...	Questionnaire A... White Button Mu...	21 Years -	City of Hope Medical Center
White Button Mushroom Extract in Preventing the Recurrence of Breast Cancer in Postmenopausal Breast Cancer Survivors	NCT00709020	Breast Cancer Cancer Survivor	white button mu... flow cytometry high performanc... laboratory biom... mass spectromet... pharmacogenomic... pharmacological...	21 Years -	City of Hope Medical Center

Spots Global Cancer Trial Database for white button mushroom extract