A Randomized Controlled Trial of Methylphenidate and a Nursing Telephone Intervention (NTI) for Fatigue in Advanced Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 2
- 主要终点
- Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue Subscale Score
研究概览
简要总结
The goal of this clinical research study is to learn if methylphenidate (Ritalin) can help to control fatigue caused by cancer. Its effect on other symptoms such as drowsiness, depression, sleeplessness, physical activity, and anxiety will also be studied. Another goal of this study is to learn if receiving a phone call by a nurse improves fatigue in patients.
详细描述
Fatigue is one of the most common problems in patients with advanced cancer. Currently, there are no treatments for managing fatigue. Methylphenidate is a stimulant that increases ability to pay attention, increases mental alertness, and decreases feelings of fatigue.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to one of 4 groups. You will have an equal chance of being placed in any of the 4 groups. You, the medical staff, and researchers will not know to which group you have been assigned.
Regardless of which group you are in, you will record your fatigue in a daily diary at breakfast, lunch, dinner, and before bedtime. Based on your level of fatigue, you will take the study drug as needed. You can take the study drug every 2 hours but you may not take more than 4 capsules a day.
Participants in Group 1 will take a methylphenidate capsule by mouth as needed to relieve symptoms of fatigue for 14 days. A nurse will call you 4-6 times in the first two weeks to ask about side effects and other symptoms. The phone calls should take about 10-20 minutes. The study nurse will set up a convenient time for you to take the phone call.
Participants in Group 2 will take a placebo capsule by mouth as needed for 14 days. A placebo is a capsule that does not contain any medication but looks just like the methylphenidate. A nurse will call you 4-6 times in the first two weeks to ask about side effects and other symptoms. The phone calls should take about 10-20 minutes. The study nurse will set up a convenient time for you to take the phone call.
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, Investigator, Outcomes Assessor)
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
- •Patients will be eligible to participate in this study if they have advanced cancer.
- •Patients will be eligible to participate in this study if they rate fatigue on the Edmonton Symptom Assessment System (ESAS) during the last 24 hours as greater than or equal to 4 on a 0-10 scale, in which 0= no fatigue and 10=worst possible fatigue
- •Describe fatigue as being present every day for most of day for a minimum of 2 weeks
- •Lack clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered normal
- •Are 18 years or older
- •Are willing to keep a daily diary, engage in telephone follow up with a nurse every other day, and return for follow-up visit after 14 days of treatment
- •Have telephone access to be contacted by the research nurse. If patient is relocating within 5 weeks, patient will be asked to provide a new telephone number
- •Hemoglobin of greater than or equal to 8 g/dl within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the past 2 weeks, one will be done to determine the eligibility. Patients with a hemoglobin of less than 8 will be referred for treatment of their anemia
- •Able to understand the description of the study and give written informed consent.
- •Able to understand the description of assessments, and able to complete baseline assessment
- •Patients on no erythropoietin or stable dose.
排除标准
- •Major contraindication to methylphenidate i.e. hypersensitivity, anxiety, tension, agitation, or motor tics, glaucoma, severe angina pectoris, or hypertension, etc.
- •Currently on methylphenidate or has been on methylphenidate within the last 10 days.
- •Inability to complete the baseline assessment forms or do understand the recommendations for participation in the study
- •Major depression according to the Structured Clinical Interview (SCID) Diagnostic and Statistical Manual of Mental Disorders (DSM) IV diagnostic criteria. These patients wil be referred immediately to psychiatry for assessment and management
- •Pregnant or lactating women
- •Requirement for Monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants or clonidine
- •Glaucoma, history of marked anxiety disorders
- •History of alcohol (CAGE questionnaire score for the last 2 years is 2 or above on a 0 to 4 scale) or substance abuse including illegal drugs and/or medications.
- •Tourette's syndrome
- •Symptomatic tachycardia and uncontrolled hypertension.
- •Currently receiving oral anticoagulants (Coumadin/warfarin), anticonvulsants (Phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine).
- •Patients with pacemakers
- •Patients with symptomatic cardiac arrhythmias
研究组 & 干预措施
Group 1: Methylphenidate + NTI
Methylphenidate 5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days + Nursing Telephone Intervention (NTI). NTI calls from study nurse 3 times weekly to ask about side effects and other symptoms.
干预措施: Nursing Telephone Intervention (Behavioral)
Group 1: Methylphenidate + NTI
Methylphenidate 5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days + Nursing Telephone Intervention (NTI). NTI calls from study nurse 3 times weekly to ask about side effects and other symptoms.
干预措施: Methylphenidate (Drug)
Group 2: Placebo + NTI
Placebo capsule orally as needed for 14 days + NTI, calls from study nurse 3 times weekly to ask about side effects and other symptoms.
干预措施: Nursing Telephone Intervention (Behavioral)
Group 2: Placebo + NTI
Placebo capsule orally as needed for 14 days + NTI, calls from study nurse 3 times weekly to ask about side effects and other symptoms.
干预措施: Placebo (Drug)
Group 3: Methylphenidate + Non NTI
Methylphenidate 5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days + Non NTI, calls from research staff 3 times weekly.
干预措施: Methylphenidate (Drug)
Group 3: Methylphenidate + Non NTI
Methylphenidate 5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days + Non NTI, calls from research staff 3 times weekly.
干预措施: Non NTI (Behavioral)
Group 4: Placebo + Non NTI
Placebo capsules as needed with Non NTI, calls from research staff 3 times weekly.
干预措施: Placebo (Drug)
Group 4: Placebo + Non NTI
Placebo capsules as needed with Non NTI, calls from research staff 3 times weekly.
干预措施: Non NTI (Behavioral)
结局指标
主要结局
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue Subscale Score
时间窗: Baseline and Day 15
FACIT-F fatigue subscale consists of 13 items. Patients rate the intensity of their fatigue symptoms on a scale of 0 to 4 (0=not at all and 4=very much). Total FACIT-F fatigue subscale score ranges from 0 to 52 with higher scores indicate higher fatigue. We measured the median change in FACIT-F fatigue sub scale score between Baseline and Day 15 using Kruskal-Wallis test.
次要结局
- Change in Edmonton Symptom Assessment System (ESAS) Fatigue Score(Baseline and Day 15)