Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
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|ClinicalTrials.gov Identifier: NCT00042848|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 15, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Fatigue Unspecified Adult Solid Tumor, Protocol Specific||Drug: modafinil||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||837 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||October 2007|
- Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042848
|Study Chair:||Gary R. Morrow, PhD, MS||James P. Wilmot Cancer Center|