A Translational Breast Cancer Prevention Trial of Mushroom Powder in Postmenopausal Breast Cancer Survivors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Optimal daily dose of WBM
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
White Button Mushroom Extract
干预措施: white button mushroom extract (Drug)
White Button Mushroom Extract
干预措施: flow cytometry (Other)
White Button Mushroom Extract
干预措施: high performance liquid chromatography (Other)
White Button Mushroom Extract
干预措施: laboratory biomarker analysis (Other)
White Button Mushroom Extract
干预措施: mass spectrometry (Other)
White Button Mushroom Extract
干预措施: pharmacogenomic studies (Other)
White Button Mushroom Extract
干预措施: pharmacological study (Other)
结局指标
主要结局
Optimal daily dose of WBM
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: Baseline prior to treatment, days 8, 15, 29, 57 and 85 after the start of treatment.
Serum sex steroid hormone levels
时间窗: Baseline prior to treatment, days 8, 15, 29, 57 and 85 after the start of treatment.
次要结局
- 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.)