Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy
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.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4
Gary R. Morrow, PhD, MS
Study Chair
James P. Wilmot Cancer Center
United States: Federal Government
CDR0000069477
NCT00042848
August 2002
October 2007
Name | Location |
---|---|
MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
CCOP - Colorado Cancer Research Program | Denver, Colorado 80224-2522 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
St. Joseph Hospital | Denver, Colorado 80218 |
Swedish Medical Center | Englewood, Colorado 80110 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Greenville | Greenville, South Carolina 29615 |
CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
CCOP - Evanston | Evanston, Illinois 60201 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
St. Mary-Corwin Regional Medical Center | Pueblo, Colorado 81004 |
Medical Center of Aurora - South Campus | Aurora, Colorado 80012-0000 |
Rocky Mountain Cancer Centers - Denver Rose | Denver, Colorado 80220 |
Rocky Mountain Cancer Centers - Thornton | Thornton, Colorado 80229 |
Rocky Mountain Cancer Centers - Longmont | Longmont, Colorado 80501 |