Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
fatigue, unspecified adult solid tumor, protocol specific
Brief summary
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.
Detailed description
OBJECTIVES: * Assess the degree to which modafinil can reduce fatigue in cancer patients receiving chemotherapy. * Assess the relationship between depression and fatigue in patients treated with this drug. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Beginning on day 5 of the second course of chemotherapy, patients receive oral modafinil once daily. * Arm II: Beginning on day 5 of the second course of chemotherapy, patients receive oral placebo once daily. Treatment in both arms continues until day 7 of course 4 of chemotherapy in the absence of disease progression or unacceptable toxicity. Fatigue and quality of life are assessed on day 7 of courses 2-4 of chemotherapy. PROJECTED ACCRUAL: A total of 837 patients will be accrued for this study within approximately 2.5 years.
Interventions
DRUGmodafinil
Sponsors
National Cancer Institute (NCI)
Gary Morrow
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed