A Randomized, Phase II Placebo-controlled Study of the Use of Extended-release Methylphenidate or Modafinil for the Treatment of Excessive Daytime Sleepiness in Children Following Cancer Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 主要终点
- Average Daytime Napping Minutes in a Week
研究概览
简要总结
RATIONALE: Methylphenidate hydrochloride or modafinil may help reduce daytime sleepiness and improve the quality of life of patients with excessive daytime sleepiness after cancer therapy. It is not yet known whether methylphenidate hydrochloride or modafinil are more effective than a placebo in reducing daytime sleepiness in these patients.
PURPOSE: This randomized phase II trial is studying methylphenidate hydrochloride or modafinil to see how well they work compared with a placebo in treating young patients with excessive daytime sleepiness after cancer therapy.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy of methylphenidate hydrochloride and modafinil to placebo in pediatric patients with excessive daytime sleepiness following cancer therapy.
Secondary
- Compare the efficacy of half dose methylphenidate hydrochloride and modafinil to placebo in these patients.
- Assess the effects of these regimens on daytime sleepiness as measured by the Pediatric Daytime Sleepiness Scale or the Cleveland Adolescent Sleepiness Questionnaire.
- Assess the effects of somnolence symptoms on fatigue as measured by the PedsQL Multidimensional Fatigue Scale.
- Assess the effects of somnolence symptoms on the quality of life as measured by the PedsQL Quality of Life Inventory 4.0.
- Determine the incidence of side effects associated with these regimens.
- Determine the prevalence of sleep complaints as measured by the Pediatric Sleep Questionnaire. (Exploratory)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 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
Arm I - methylphenidate hydrochloride
Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
干预措施: methylphenidate hydrochloride (Drug)
Arm II -modafinil
Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
干预措施: modafinil (Drug)
Arm III placebo
Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
干预措施: placebo (Drug)
结局指标
主要结局
Average Daytime Napping Minutes in a Week
时间窗: 29 days
Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries
次要结局
- Adverse Events(29 days)