A Phase II, Randomized, Double-blind, Placebo Controlled Trial of Methylphenidate Hydrochloride for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH-Agonist Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- To assess the ability of methylphenidate 5 mg BID (10 mg daily) to reduce LHRH-agonist-related fatigue in prostate cancer patients as measured by the Functional Assessment of Cancer Therapy Fatigue subscale (FACT-F).
研究概览
简要总结
The purpose of this study is to determine if methylphenidate improves fatigue in men undergoing hormonal therapy for prostate cancer with an LHRH-agonist.
详细描述
This study will determine if methylphenidate improves fatigue in men undergoing hormonal therapy for prostate cancer. Fatigue is a common problem experienced by cancer patients. Those patients who are receiving chemotherapy or radiation are especially vulnerable to fatigue, as are men with prostate cancer who are receiving hormonal therapy with an LHRH-agonist (androgen deprivation therapy). Eligible men will be randomized to a daily dose of 10 mg methylphenidate or placebo for a total treatment period of 12 weeks. Subjects will be monitored for changes in fatigue and mood during this period. While the exact cause of fatigue in this setting is unknown, this study will hopefully lead to a better understanding of the process and provide patients with a much-needed remedy for fatigue
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
干预措施: Methylphenidate Hydrochloride (Drug)
2
干预措施: Matched Placebo (Drug)
结局指标
主要结局
To assess the ability of methylphenidate 5 mg BID (10 mg daily) to reduce LHRH-agonist-related fatigue in prostate cancer patients as measured by the Functional Assessment of Cancer Therapy Fatigue subscale (FACT-F).
时间窗: 3 months pre-treatment (LHRH-agnost naive group only), randomization, 6 weeks, 10 weeks, 12 weeks, 24 weeks
次要结局
- Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Bruera Global Fatigue Severity Scale(Screening Visit 1, 3 months pre-treatment (LHRH-agonist naive group only), Screening Visit 2 (LHRH-agonist naive group only), Randomization, 2 weeks, 6 weeks, 10 weeks, 12 weeks, 24 weeks)
- Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Centre for Epidemiological Studies Depression Scale(CESD)(Screening Visit 1, 3 months pre-treatment (LHRH-agonist naive group only), Screening Visit 2 (LHRH-agonist naive group only), Randomization, 6 weeks, 10 weeks, 24 weeks)
- Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Medical Outcomes Study 36-Item Short Form (SF-36)(3 months pre-treatment (LHRH-agonist naive group only), Randomization, 6 weeks, 10 weeks, 24 weeks)
研究者
Dr. Neil Fleshner
MD, MPH, FRCSC
University Health Network, Toronto