Patient Controlled Methylphenidate for Cancer Related Fatigue: A Double Blind, Randomized, Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- To establish the effectiveness of patient the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score: 0-10 numerical scale.
研究概览
简要总结
To determine the effectiveness of patient controlled methylphenidate as compared to placebo for the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score.
详细描述
Primary objective:
-To determine the effectiveness of patient controlled methylphenidate as compared to placebo for the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score
Secondary objective
- To assess the efficacy of as needed methylphenidate on pain, sedation and quality of life.
- To assess the potential side effects of methylphenidate on appetite, insomnia and anxiety
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
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of fatigue on a numerical scale during the last 24 hours of more or equal to 4 on a 0 to 10 scale in which 0 equals no fatigue and 10 worst possible fatigue.
- •Patients should describe fatigue as being present for a minimum of four days.
- •If patients are on opioids for the treatment of cancer pain, change of opioids is allowed.
- •No clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered as normal.
- •Sign written informed consent.
- •Patients must be 18 years or older.
- •Patient willing to keep a daily diary, engage in daily telephone follow up with a nurse, and after 7 days of treatment patient will return for a follow up visit.
- •Patient must have telephone access to be contacted daily by the research nurse.
- •Hemoglobin of >/=10 g/dl within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the past two weeks, one will be done to determine the eligibility.
排除标准
- •Major contraindication to methylphenidate i.e. hypersensitivity, anxiety, tension, agitation, or motor tics
- •Currently on methylphenidate or has been on methylphenidate within the last 10 days.
- •Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study.
- •Pregnant or lactating women.
- •Patients taking MAO inhibitors, tricyclic antidepressants and clonidine.
- •Patients with glaucoma, history of marked anxiety disorder, or history of substance abuse.
- •CAGE questionnaire score for the last 2 years is 2 or above on a 0 to 4 scale
- •History of Tourette's syndrome
- •Patients with tachycardia and uncontrolled hypertension.
研究组 & 干预措施
Methylphenidate
treatment of attention deficit disorder and narcolepsy (sleep disorder)
干预措施: Methylphenidate (Drug)
Methylphenidate
treatment of attention deficit disorder and narcolepsy (sleep disorder)
干预措施: Placebo (Sugar Pill) (Other)
Placebo
Sugar pill
干预措施: Methylphenidate (Drug)
Placebo
Sugar pill
干预措施: Placebo (Sugar Pill) (Other)
结局指标
主要结局
To establish the effectiveness of patient the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score: 0-10 numerical scale.
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点