Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

Study Overview
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Brief Summary
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RATIONALE: Modafinil may be effective in relieving fatigue in patients with cancer who are undergoing chemotherapy. The effectiveness of modafinil in relieving chemotherapy-related fatigue is not yet known. PURPOSE: This randomized phase III trial is studying the effectiveness of modafinil in treating fatigue in patients who are receiving chemotherapy for cancer.

Detailed Description
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OBJECTIVES: Assess the degree to which modafinil can reduce fatigue in cancer patients receiving chemotherapy. Assess the relationship between depression and fatigue in patients treated with this drug. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Beginning on day 5 of the second course of chemotherapy, patients receive oral modafinil once daily. Arm II: Beginning on day 5 of the second course of chemotherapy, patients receive oral placebo once daily. Treatment in both arms continues until day 7 of course 4 of chemotherapy in the absence of disease progression or unacceptable toxicity. Fatigue and quality of life are assessed on day 7 of courses 2-4 of chemotherapy. PROJECTED ACCRUAL: A total of 837 patients will be accrued for this study within approximately 2.5 years.

Official Title
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Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy

Conditions
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Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: modafinil


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of cancer Concurrently receiving or has previously received chemotherapy and is scheduled for at least 3 additional courses of chemotherapy Each course of chemotherapy must be at least 2 weeks in duration No concurrent radiotherapy or interferon therapy Brief Fatigue Inventory question #3 fatigue worst score of 2 or greater 1 week after first chemotherapy course PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy At least 6 months Hematopoietic Not specified Hepatic No uncontrolled anemia Renal Not specified Cardiovascular No history of clinically significant cardiac disease, including any of the following: Unstable angina Left ventricular hypertrophy Ischemic echocardiogram changes Chest pain Arrhythmia Other clinically significant manifestations of mitral valve prolapse in association with use of central nervous system stimulants (e.g., caffeine, amphetamines, or methylphenidate) No uncontrolled hypertension Gastrointestinal Able to swallow medication No narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract Other No severe headaches No glaucoma No seizure disorder No narcolepsy No psychotic disorder No Tourette's syndrome No alcohol or drug abuse Not pregnant or nursing Fertile patients must use effective barrier contraception during and for at least 1 full menstrual cycle after study completion PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy See Disease Characteristics Endocrine therapy No concurrent chronic corticosteroids Radiotherapy See Disease Characteristics Surgery Not specified Other No prior modafinil At least 30 days since prior regular use of psychostimulants (e.g., amphetamines, methylphenidate, or pemoline) or monoamine oxidase inhibitors (MAOIs) No concurrent alcohol Concurrent acetaminophen with codeine or hydrocodone bitartrate allowed Concurrent phenytoin allowed Concurrent warfarin for anticoagulation and low-dose warfarin (1 mg by mouth daily) for maintenance of venous access devices allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: modafinil|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between depression and fatigue during chemotherapy as assessed by Fatigue Symptom Checklist, Profile of Mood States, Fatigue Severity Scale, Epworth Sleepiness Scale, Center for Epidemiologic Studies-Depression, and Mini-Mac at course 4 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, unspecified adult solid tumor, protocol specific