White Button Mushroom Extract in Preventing the Recurrence of Breast Cancer in Postmenopausal Breast Cancer Survivors
- Conditions
- Breast CancerCancer Survivor
- Interventions
- Drug: white button mushroom extractOther: flow cytometryOther: high performance liquid chromatographyOther: laboratory biomarker analysisOther: mass spectrometryOther: pharmacogenomic studiesOther: pharmacological study
- Registration Number
- NCT00709020
- Lead Sponsor
- City of Hope Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description White Button Mushroom Extract white button mushroom extract - White Button Mushroom Extract flow cytometry - White Button Mushroom Extract high performance liquid chromatography - White Button Mushroom Extract laboratory biomarker analysis - White Button Mushroom Extract mass spectrometry - White Button Mushroom Extract pharmacogenomic studies - White Button Mushroom Extract pharmacological study -
- Primary Outcome Measures
Name Time Method Optimal daily dose of WBM 1 year after completion of the study Pharmacokinetics of C-18 unsaturated fatty acids (CUFA) as measured by high-performance liquid chromatography tandem-mass spectrometry 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. Pharmacodynamics of WBM as measured by ex vivo plasma aromatase inhibition assays 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. Efficacy of white button mushroom extract (WBM) in reducing serum estradiol (E2) Baseline prior to treatment, days 8, 15, 29, 57 and 85 after the start of treatment. Serum sex steroid hormone levels Baseline prior to treatment, days 8, 15, 29, 57 and 85 after the start of treatment.
- Secondary Outcome Measures
Name Time Method Safety and tolerability of WBM as assessed by NCI CTCAE v3.0, symptom logs, bone metabolism markers, and pre- and post-treatment comprehensive lipid panels 4 months after completion of treatment Barriers to recruitment of ethnically diverse patients from the community 4 months after completion of treatment Dietary sources of CUFA as measured by food frequency questionnaires Day -14 before treatment begins, day 1, 29, 57 and 85 after treatment begins Bone metabolism markers (i.e., serum procollagen type-1 propeptide and urine N-telopeptide crosslinks) Day 1 of treatment and day 85 of treatment Fasting lipids (i.e., total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides) Day 1 of treatment and day 85 of treatment Effect of WBM on cytokines as measured by multiplex cytokine analyses Day -14 and Day -7 before first treatment, Day 1, 8, 15, 29, 57 and 85 after treatment begins. Effect of WBM on innate and adaptive cellular immunity as measured by immunologic assays Day -14 and Day -7 before first treatment, Day 1, 8, 15, 29, 57 and 85 after treatment begins.
Trial Locations
- Locations (2)
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
City of Hope Medical Group
🇺🇸Pasadena, California, United States