NCT00110136终止2 期
A Phase II Study of St. John's Wort for the Treatment of Hot Flashes in Women With a History of Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 19
- 主要终点
- Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks
研究概览
简要总结
RATIONALE: St. John's wort may help relieve hot flashes in women with breast cancer.
PURPOSE: This phase II trial is studying how well St. John's wort works in relieving hot flashes in women with non-metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of Hypericum perforatum (St. John's wort) in alleviating hot flashes, in terms of hot flash frequency, score, and duration and disruption of daily activities caused by hot flashes, in postmenopausal women with non-metastatic breast cancer.
- Determine hot flash changes over 4 weeks in patients treated with this drug.
Secondary
- Determine the toxicity of this drug in these patients.
- Determine the effect of Hypericum perforatum (St. John's wort) on serum tamoxifen levels in women receiving tamoxifen therapy.
- Determine the effect of Hypericum perforatum (St. John's wort) on general health-related quality of life and mood at 2 and 4 weeks relative to baseline, and during the 2 week post-treatment phase in these patients.
- To evaluate changes in average weekly hot flush scores and duration over course of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 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
St. John's Wort
Experimental
Patient given one 300mg St. John's Wort tablet three times per day
干预措施: St. John's Wort (Drug)
结局指标
主要结局
Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks
时间窗: Baseline and four weeks
Primary objective was to assess the change in hot flashes over a four week period in patients given St. John's Wort
次要结局
- Effect of St. John's Wort on Hot Flash Score as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks(Baseline and four weeks)
- Estimation of Toxicities While on St. John's Wort(Six weeks following baseline (four weeks of active treatment and two weeks of follow-up))
- Effect of St. John's Wort on Quality of Life (PCS)(Baseline and four weeks)
- Mood is Measured by the POMS Short Form.(Baseline and four weeks)
- Effect of St. John's Wort on Quality of Life (MCS)(Baseline and four weeks)
研究者
研究点 (19)
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