Modafinil in Treating Fatigue in Patients With Cancer

Study Overview
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Brief Summary
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RATIONALE: Modafinil may help relieve fatigue and improve quality of life in patients with cancer. PURPOSE: This clinical trial is studying how well modafinil works in treating fatigue in patients with cancer.

Detailed Description
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OBJECTIVES: Primary Determine the safety of modafinil in cancer patients. Determine the efficacy of this drug, in terms of improving fatigue, in these patients. Secondary Determine the efficacy of this drug, in terms of improving mood, cognitive ability, functional status, and quality of life, in these patients. OUTLINE: This is a nonrandomized, pilot study. Patients receive oral modafinil once daily for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive additional modafinil at the discretion of the physician. Fatigue, mood, cognition, functional status, and quality of life are assessed at baseline and in weeks 2 and 4. After completion of study treatment, patients are followed at 30 days. PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study within 9 months.

Official Title
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Pilot Study Evaluating the Safety and Efficacy of Modafinil in Improving Fatigue, Mood, Cognitive Ability, Functional Status, and Quality of Life of Cancer Patients

Conditions
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Cognitive/Functional Effects, Depression, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: modafinil
* Procedure: cognitive assessment
* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of cancer Brief Fatigue Inventory score ≥ 4 PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 1-3 Life expectancy At least 2 months Hematopoietic Not specified Hepatic Not specified Renal Not specified Cardiovascular No history of left ventricular hypertrophy No history of ischemic ECG changes No history of chest pain No history of arrhythmia No history of other clinically significant manifestations of mitral valve prolapse in association with CNS stimulant use Other Not pregnant or nursing Negative pregnancy test Thyroid stimulating hormone normal No known hypersensitivity to modafinil No history of psychotic disorder and/or active psychosis No history of any chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation or compliance PRIOR CONCURRENT THERAPY: Biologic therapy Concurrent thalidomide allowed Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other Concurrent narcotics, phenothiazines, or benzodiazepines allowed No other concurrent investigational therapy

Ages Eligible for Study
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Minimum Age: 18 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: modafinil|nan|
|Procedure: cognitive assessment|nan|
|Procedure: psychosocial assessment and care|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, in terms of adverse events and dose-limiting toxicity, as measured by NCI CTC v2.0 at up to 4 weeks after the start of treatment |  |  | 
| Fatigue as measured by Brief Fatigue Inventory at 2 and 4 weeks after the start of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood as measured by Hamilton Rating Scale for Depression at 2 and 4 weeks after the start of treatment |  |  | 
| Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Hopkins Verbal Learning Test at 2 and 4 weeks after start of treatment |  |  | 
| Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Grooved Pegboard Test at 2 and 4 weeks after start of treatment |  |  | 
| Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Controlled Oral Word Association Test from the Multilingual Aphasia Examination at 2 and 4 weeks after start of treatment |  |  | 
| Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Trail Making Test A and B at 2 and 4 weeks after start of treatment |  |  | 
| Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Recall and Recognition of Word List encoded from the Hopkins Verbal Learning Test at 2 and 4 weeks after start of treatment |  |  | 
| Functional status as measured by Barthel Index and ECOG performance status at 2 and 4 weeks after the start of treatment |  |  | 
| Quality of life as measured by Functional Assessment of Cancer Therapy-Br at 2 and 4 weeks after the start of treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, depression, cognitive/functional effects, unspecified adult solid tumor, protocol specific