A Pilot Study of the Effects of Vitamin B6 on Hot Flash Symptoms in Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)
研究概览
简要总结
This pilot phase II trial studies how well vitamin B6 works in reducing hot flashes in participants with prostate cancer undergoing antiandrogen therapy. A nutritional supplement such as vitamin B6 may help improve hot flashes caused by antiandrogen therapy in participants with prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the effect of Vitamin B6 in improves the frequency or severity of hot flashes in prostate cancer patients receiving antiandrogen therapy (androgen deprivation therapy [ADT]).
OUTLINE:
Participants receive vitamin B6 orally (PO) daily for 12 weeks.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects are currently receiving ADT for prostate cancer and will continue on ADT for at least 13 weeks after enrollment. Patient may have been started on ADT at any past time point because patients experience hot flashes throughout ADT treatment
- •Subjects are experiencing bothersome hot flashes per the study questionnaires
- •Subjects are capable of giving informed consent.
- •Willing to comply with all study procedures and be available for the duration of the study
- •Able to obtain and take an acceptable form of vitamin B6
排除标准
- •Subjects without a diagnosis of prostate cancer
- •Subjects already receiving other treatment for hot flashes
- •Subjects taking selective serotonin reuptake inhibitors (SSRIs)
- •Subjects are currently taking vitamin supplementation which includes vitamin B6 at doses > 10 mg
结局指标
主要结局
Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)
时间窗: Baseline to 8 weeks
For the primary analysis, the difference in the median response to the 10-point hot flash scale between 8-week post-treatment and pre-treatment responses will be computed with the corresponding 95% percent confidence interval. The primary null hypothesis will be tested using a two-sided Wilcoxon Signed-Rank Test with alpha=0.05.
次要结局
- Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)(Baseline to 12 weeks)