Clinical trial · Interventional
Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy
NCT00042848CI-TRIAL-00019477completedPhase 3ClinicalTrials.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 be effective in relieving fatigue in patients with cancer who are undergoing chemotherapy. The effectiveness of modafinil in relieving chemotherapy-related fatigue is not yet known. PURPOSE: This randomized phase III trial is studying the effectiveness of modafinil in treating fatigue in patients who are receiving chemotherapy for cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| modafinil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4
Secondary outcomes (1)
- measure
- Relationship between depression and fatigue during chemotherapy as assessed by Fatigue Symptom Checklist, Profile of Mood States, Fatigue Severity Scale, Epworth Sleepiness Scale, Center for Epidemiologic Studies-Depression, and Mini-Mac at course 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of cancer * Concurrently receiving or has previously received chemotherapy and is scheduled for at least 3 additional courses of chemotherapy * Each course of chemotherapy must be at least 2 weeks in duration * No concurrent radiotherapy or interferon therapy * Brief Fatigue Inventory question #3 "fatigue worst" score of 2 or greater 1 week after first chemotherapy course PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * At least 6 months Hematopoietic * Not specified Hepatic * No uncontrolled anemia Renal * Not specified Cardiovascular * No history of clinically significant cardiac disease, including any of the following: * Unstable angina * Left ventricular hypertrophy * Ischemic echocardiogram changes * Chest pain * Arrhythmia * Other clinically significant manifestations of mitral valve prolapse in association with use of central nervous system stimulants (e.g., caffeine, amphetamines, or methylphenidate) * No uncontrolled hypertension Gastrointestinal * Able to swallow medication * No narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract Other * No severe headaches * No glaucoma * No seizure disorder * No narcolepsy * No psychotic disorder * No Tourette's syndrome * No alcohol or drug abuse * Not pregnant or nursing * Fertile patients must use effective barrier contraception during and for at least 1 full menstrual cycle after study completion PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * See Disease Characteristics Endocrine therapy * No concurrent chronic corticosteroids Radiotherapy * See Disease Characteristics Surgery * Not specified Other * No prior modafinil * At least 30 days since prior regular use of psychostimulants (e.g., amphetamines, methylphenidate, or pemoline) or monoamine oxidase inhibitors (MAOIs) * No concurrent alcohol * Concurrent acetaminophen with codeine or hydrocodone bitartrate allowed * Concurrent phenytoin allowed * Concurrent warfarin for anticoagulation and low-dose warfarin (1 mg by mouth daily) for maintenance of venous access devices allowed
References
Publications (1)
- RESULTJean-Pierre P, Morrow GR, Roscoe JA, Heckler C, Mohile S, Janelsins M, Peppone L, Hemstad A, Esparaz BT, Hopkins JO. A phase 3 randomized, placebo-controlled, double-blind, clinical trial of the effect of modafinil on cancer-related fatigue among 631 patients receiving chemotherapy: a University of Rochester Cancer Center Community Clinical Oncology Program Research base study. Cancer. 2010 Jul 15;116(14):3513-20. doi: 10.1002/cncr.25083. PMID 20564068