NCT01669460已完成2 期
A Phase II, Open Label Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reduction in overall fatigue as measured by Bruera global fatigue severity scale.
研究概览
简要总结
The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce fatigue in prostate cancer patients receiving LHRH agonist therapy.
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 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed prostate cancer
- •Currently receiving LHRH-agonist therapy for greater than 6 months
- •Measurable fatigue, defined as a score of ≥ 2 on the Bruera global fatigue severity scale
- •Able to swallow Red Bull™ Sugar-Free Drink
- •Life expectancy of at least 1 year
- •Able to read and write in English
- •Willing to limit consumption of alcohol to one drink per day
排除标准
- •Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (exceptions are superficial bladder cancer or non-melanoma skin cancer)
- •Myocardial infarction within past 6 months
- •Any unstable serious co-existing medical condition(s) including but not limited to unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, severe bleeding diseases or immune disorders
- •Evidence of drug or alcohol abuse
- •Known hypersensitivity to caffeine
- •Known history of liver and kidney insufficiencies
- •Known contraindications to Red Bull™ use
结局指标
主要结局
Reduction in overall fatigue as measured by Bruera global fatigue severity scale.
时间窗: Within 4 days after completion of intervention (28 days of Red Bull™)
次要结局
- Overall improvement in quality of life as measured by the Medical Outcomes Study Short-Form (SF-36)(Within 4 days after completion of intervention (28 days of Red Bull™))
研究者
研究点 (2)
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