Trials / Completed
CompletedNCT00042848
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 837 (estimated)
- Sponsor
- Gary Morrow · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | modafinil |
Timeline
- Start date
- 2002-08-01
- Primary completion
- 2007-04-01
- Completion
- 2007-10-01
- First posted
- 2003-01-27
- Last updated
- 2015-10-15
Locations
35 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00042848. Inclusion in this directory is not an endorsement.