Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
INTERVENTIONAL
2004-02-29
Brief Summary
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PURPOSE: This clinical trial is studying how well modafinil works in treating fatigue in patients with cancer.
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Detailed Description
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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.
Conditions
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Study Design
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SUPPORTIVE_CARE
Interventions
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modafinil
cognitive assessment
psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Virginia
OTHER
Principal Investigators
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Leslie Blackhall, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of Virginia Cancer Center
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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UVACC-HIC-10951
Identifier Type: -
Identifier Source: secondary_id
UVACC-30603
Identifier Type: -
Identifier Source: secondary_id
CDR0000432953
Identifier Type: -
Identifier Source: org_study_id
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