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Charlottesville, Virginia 22908

  • Unspecified Adult Solid Tumor, Protocol Specific


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.

Study summary:

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.


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



Primary Contact:

Principal Investigator
Leslie Blackhall, MD
University of Virginia

Backup Contact:


Location Contact:

Charlottesville, Virginia 22908
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source:

Date Processed: April 03, 2020

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