Clinical trial · Interventional
Modafinil in Treating Fatigue in Patients With Cancer
Pilot Study Evaluating the Safety and Efficacy of Modafinil in Improving Fatigue, Mood, Cognitive Ability, Functional Status, and Quality of Life of Cancer Patients
NCT00112515CI-TRIAL-00002561unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cognitive assessment | Procedure | — | UNRESOLVED |
| modafinil | Drug | — | UNRESOLVED |
| psychosocial assessment and care | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- 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
- measure
- Fatigue as measured by Brief Fatigue Inventory at 2 and 4 weeks after the start of treatment
Secondary outcomes (8)
- measure
- Mood as measured by Hamilton Rating Scale for Depression at 2 and 4 weeks after the start of treatment
- measure
- 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
- measure
- 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
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.