Status:
UNKNOWN
Modafinil in Treating Fatigue in Patients With Cancer
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cognitive/Functional Effects
Depression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 wi...
Detailed Description
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 effic...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00112515
Start Date
February 1 2004
Last Update
August 20 2009
Active Locations (1)
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1
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908