A Pilot Phase II Trial of Magnesium Supplements to Reduce Menopausal Hot Flashes in Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5)
研究概览
简要总结
RATIONALE: Magnesium oxide may help relieve hot flashes in women with cancer.
PURPOSE: This phase II trial is studying how well magnesium oxide works in treating hot flashes in menopausal women with cancer.
详细描述
OBJECTIVES:
Primary
- To determine if magnesium oxide supplement will decrease the frequency and severity of hot flashes by 50% in menopausal women with cancer.
Secondary
- To evaluate the effect of magnesium oxide on overall quality of life.
- To evaluate the toxicities of magnesium oxide when administered at commonly used supplement doses.
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
Supportive care (magnesium oxide)
Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
干预措施: magnesium oxide (Drug)
Supportive care (magnesium oxide)
Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
干预措施: questionnaire administration (Other)
Supportive care (magnesium oxide)
Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5)
时间窗: from baseline to week 5
Hot flash score (frequency x severity) at baseline was compared to the end of treatment. The number of flashes in a 24 hour day and a score combining the number and severity of hot flashes (ie, 1 point for mild, 2 points for moderate, 3 points for severe and 4 points for very severe.
次要结局
- Difference in Quality of Life(from baseline to week 5)