A Prospective Trial of Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens
研究概览
简要总结
To determine the efficacy of soy/isoflavone supplementation on hot flashes in men who are being treated with luteinizing hormone-releasing hormone (LHRH) agonist therapy for control of advanced prostate cancer
详细描述
Literature has shown that low dose estrogens can control hot flashes in men on androgen deprivation but with a high risk of thromboembolic events. Soy derivatives that contain isoflavones, a type of phytoestrogen, have been evaluated in peri-menopausal women as a possible safer alternative to synthetic estrogens but there has not been a similar study performed on their effect in men on androgen deprivation therapy for prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven adenocarcinoma of prostate with treatment of prostate cancer (radical prostatectomy, radiation therapy, etc.)
- •had biochemical/clinical relapse and started on antiandrogens
- •have documented history of hot flashes
排除标准
- •History of MI, DVT, CVA
- •peanut allergy
- •untreated hypothyroidism
- •must be off other medical treatment for hot flashes for 2 weeks before enrollment in this study
研究组 & 干预措施
1
Subjects receive supplement
干预措施: Flav-ein capsules (Dietary Supplement)
2
Subjects will receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens
时间窗: 16 Weeks
次要结局
未报告次要终点