Fatigue Clinical Trial
Official title:
Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
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