Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
- Conditions
- FatigueUnspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00042848
- Lead Sponsor
- Gary Morrow
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 837
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (35)
St. Mary-Corwin Regional Medical Center
🇺🇸Pueblo, Colorado, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
Rocky Mountain Cancer Centers - Thornton
🇺🇸Thornton, Colorado, United States
Rocky Mountain Cancer Centers - Longmont
🇺🇸Longmont, Colorado, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Sky Ridge Medical Center
🇺🇸Lone Tree, Colorado, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
Boulder Community Hospital
🇺🇸Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸Colorado Springs, Colorado, United States
CCOP - Metro-Minnesota
🇺🇸St. Louis Park, Minnesota, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program
🇺🇸Denver, Colorado, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Rocky Mountain Cancer Centers - Denver Rose
🇺🇸Denver, Colorado, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
CCOP - Hematology-Oncology Associates of Central New York
🇺🇸East Syracuse, New York, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Goldsboro, North Carolina, United States
Medical Center of Aurora - South Campus
🇺🇸Aurora, Colorado, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States