Angelica Sinensis for the Treatment of Hot Flashes in Men Undergoing Androgen Deprivation Therapy for Prostate Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- assess bone loss in men with prostate cancer being treated with LHRH
研究概览
简要总结
Men undergoing androgen deprivation therapy for prostate cancer may experience significant side effects including symptoms of intense heat, facial flushing, and sweating. These so-called hot flashes are similar to those experienced by women during menopause. A traditional Chinese herbal preparation, Dong Quai, has been used for thousands of years to reduce the incidence and severity of hot flashes. Anecdotal evidence exists to support the use of Dong Quai in men treated with androgen deprivation therapy for prostate cancer.
Recently, the awareness and use of herbal remedies and over-the-counter preparations for a number of different conditions have increased dramatically. This trial was, therefore, designed to determine if Dong Quai significantly reduces the incidence and severity of hot flashes in men following androgen deprivation therapy for prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer treated with some form of androgen deprivation therapy for at least one month. This includes either surgical (bilateral orchidectomy) or medical (LHRH agonist, pure or steroidal antiandrogen or combined) castration;
- •Greater than seven vasomotor episodes per week;
- •Significantly bothersome symptoms associated with these vasomotor episodes, which produce a desire in the patient to seek treatment to reduce both their incidence and severity;
- •Documented informed consent to participate in the trial.
排除标准
- •Enrolment in any other clinical trial or study protocol;
- •Presence of pain due to prostate cancer;
- •Life expectancy less than three months;
- •Any severe concomitant condition that would make it undesirable, in the clinician's opinion, or the subject to participate in the trial or would jeopardize compliance with the trial protocol;
- •Concomitant anticoagulation therapy or history of bleeding disorder or blood dyscrasia;
- •Known hypersensitivity to Dong Quai.
研究组 & 干预措施
1
Angelica Sinensis
干预措施: Angelica Sinensis (Drug)
2
placebo
干预措施: Angelica Sinensis (Drug)
结局指标
主要结局
assess bone loss in men with prostate cancer being treated with LHRH
时间窗: at each of 3 follow up visits
次要结局
未报告次要终点