modafinil in treating fatigue in patients receiving chemotherapy for cancer

Conditions: Fatigue; Unspecified Adult Solid Tumor, Protocol Specific

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.

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.

Eligibility 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

Keywords: fatigue unspecified adult solid tumor, protocol specific