Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- To investigate the efficacy of sustained-release, transdermal methylphenidate compared to a placebo.
研究概览
简要总结
The purpose of this study is to compare the effects, good and/or bad, of the Methylphenidate patch and a placebo patch (a patch that contains no medicine) on patients and their fatigue caused by cancer or by cancer treatment. The Methylphenidate patch contains a medication that is known to increase alertness and wakefulness. Oral methylphenidate has been used in the past to treat cancer related fatigue and is often used to treat unusual sleepiness. But this is the first time that the patch form is offered to try treating cancer fatigue in patients who cannot always swallow tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of head and neck cancer who underwent combined modality treatment with curative intent
- •Has not undergone cancer treatment in the last 4 weeks
- •Is 21 years of age or older
- •Fatigue scale score of 4 or higher
- •Is able to understand English, through written and verbal communication
- •In the judgment of the consenting professional, is able to provide informed consent
- •Physically able to present for follow-up appointments at outpatient Radiation Oncology or Pain & Palliative Care clinics
- •Probable life expectancy of more than 6 months
排除标准
- •Pulmonary or cardiovascular failure, seizure disorder, sleep disorder, mental impairment, psychiatric disorder, or pregnancy
- •Has known sensitivity or allergies to methylphenidate
- •Receiving concurrent treatment with a psychostimulant
- •Hospitalized patients
- •Evidence of impaired hepatic or renal function (hyperbilirubinemia, greater than two fold elevation of transaminases; >40mg/dl BUN or >1.5mg/dl Cr )
- •Anemia ( hemoglobin <10mg/dl)
研究组 & 干预措施
methylphenidate via transdermal patch compared to placebo
The proposed study is a within-subject, cross-over, randomized and double-blinded pilot trial, designed to evaluate the efficacy and feasibility of sustained-release, long-acting methylphenidate via transdermal patch compared to placebo in fatigued patients with Head and Neck malignancies
干预措施: methylphenidate via transdermal patch compared to placebo (Drug)
结局指标
主要结局
To investigate the efficacy of sustained-release, transdermal methylphenidate compared to a placebo.
时间窗: for 10 days
In reducing fatigue, increasing activity levels, and sustaining steady wakefulness throughout the day. The outcome measure will be BFI and ESS based self-reporting of the reduction of numeric rating scale on fatigue level and sleepiness, combined with objective measurement of increased activity intensity scores monitored by actigraphy.
To evaluate the possible side effects of a methylphenidate patch.
时间窗: for 10 days
In adult head and neck cancer patients with fatigue.
次要结局
- To evaluate the feasibility of accelerometry-based objective outcome measures to assess improved activity levels and energy expenditure of cancer patients.(for 10 days)