Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- degree to which modafinil can reduce patient fatigue following treatment for cancer
研究概览
简要总结
The purpose of this study is to determine the efficacy of modafinil with regard to reducing cancer-related fatigue in cancer patients following chemotherapy or radiation therapy. Secondarily, the effect of modafinil on cognitive dysfunction in the same population will be assessed.
The researchers hypothesize that administering modafinil (PROVIGIL®) to patients experiencing fatigue following completion of cancer treatment will lead to reduction in patient fatigue and prevention of or improvement in patient cognitive dysfunction.
详细描述
Fatigue is a very common and troublesome side effect experienced in cancer patients before, during and after chemotherapy and radiation treatment. This protocol will increase knowledge about the occurrence and treatment of fatigue that develops during cancer treatments with the rationale that:
- better control of the fatigue reported by patients during and following cancer treatment is needed,
- there are few systematic data on the etiology of fatigue following cancer treatment, and
- there is evidence indicating that chemotherapy is associated with cognitive dysfunction.
Comparisons: In this randomized, placebo-controlled study of cancer patients following their chemotherapy or radiation therapy, we will assess the efficacy of modafinil for relieving cancer-related fatigue by actigraphy and for preventing or improving cognitive dysfunction by computer-generated tasks that have previously been utilized to examine drug-induced changes in performance (CDR Cognitive Assessment). Additional outcome measures will include the Fatigue Symptom Checklist, POMS, Fatigue Severity Scale, sleepiness measured by the Epworth Sleepiness Scale, cytokine blood levels, depression measured by the CES-D, and psychological adjustment to cancer measured by the Mini-MAC.
The primary objective is to:
- compare changes in patient reported fatigue following completion of chemotherapy and/or radiation treatment for cancer in patients who receive open-label modafinil (PROVIGIL®) for 4 weeks
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
- Quadruple (Participant, Care Provider, 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
- •Patient is longer than one-month post chemotherapy and/or radiation treatment for an initial diagnosis of cancer
- •Patient is 18 years of age or older
- •Patient is able to swallow medication
- •Patient has a Brief Fatigue Inventory (BFI) question #3 "fatigue worst" score of 2 or greater
排除标准
- •Patient has ever taken modafinil (PROVIGIL)
- •Patient has taken an anticonvulsant for a seizure disorder; has taken any of the following on a regular basis within the past 30 days, a psychostimulant (e.g., amphetamines, methylphenidate [Ritalin], pemoline [Cylert]), or a monoamine oxidase inhibitor (MAOIs)
- •Patient has a history of clinically significant cardiac disease, uncontrolled hypertension, alcohol or drug abuse, severe headaches, glaucoma, seizure disorder, narcolepsy, a psychotic disorder, or Tourette's syndrome
- •Patient presently taking on a regular basis:
- •an anticoagulant (Coumadin [warfarin], heparin); note that low dose Coumadin (1 mg by mouth daily) given for maintenance of venous access devices is acceptable
- •alpha-interferon or interleukin-2,
- •a corticosteroid (dexamethasone, prednisone, prednisolone)
- •Patient has a narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract
- •Patient is currently pregnant or nursing (if currently using a steroidal contraceptive for fertility control, participant must agree to use a barrier method of contraception during the study and for one full menstrual cycle following the study
- •Patient has uncontrolled anemia; receiving treatment for anemia and currently stable is acceptable
研究组 & 干预措施
Modafinil
Modafinil 200 mg taken by mouth once a day. Subjects will take 2 100 mg tablets each morning.
干预措施: Modafinil (Drug)
placebo
Inactive sugar pill, 2 are taken once a day in the morning
干预措施: sugar pill (Drug)
结局指标
主要结局
degree to which modafinil can reduce patient fatigue following treatment for cancer
时间窗: 4 weeks
次要结局
- cytokine blood levels
- depression measured by the Center for Epidemiologic Studies-Depression scale (CES-D)
- psychological adjustment to cancer measured by the Mini-Mental Adjustment to Cancer scale (Mini-MAC)
- cognitive function measured by the Cognitive Drug Research (CDR) Cognitive Assessment
研究者
Gary Morrow
Professor
University of Rochester