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Modafinil for Fatigue in Cancer Patients Receiving Chemotherapy
NCT00042848Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2002
- Primary completion
- Apr 2007
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- modafinil
- Conditions
- cancer-related fatigue (CRF)
01
Overview
Phase 3, randomised, double-blind trial in cancer-related fatigue (CRF) comparing Modafinil with Placebo (2 arms). Primary endpoint: Brief Fatigue Inventory Score. Started Aug 2002; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Modafinil
Oral modafinil once daily.
Placebo
Oral placebo once daily.
03
Who it enrols
Adult cancer patients currently receiving chemotherapy with a life expectancy of at least 6 months and experiencing fatigue (score >= 2 on BFI). Patients must not have uncontrolled anemia, clinically significant cardiac disease, severe headaches, glaucoma, seizure disorder, narcolepsy, or psychotic disorders.
04
Endpoints
Primary
Brief Fatigue Inventory Score
Secondary
Relationship between depression and fatigue
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