Finding studies
Finding studies
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Lead
Gary Morrow
With
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.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted