Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
OBJECTIVES:
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Assess the degree to which modafinil can reduce fatigue in cancer patients receiving chemotherapy.
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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.
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Arm I: Beginning on day 5 of the second course of chemotherapy, patients receive oral modafinil once daily.
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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 Design
Outcome Measures
Primary Outcome Measures
- Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4 []
Secondary Outcome Measures
- 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 []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Diagnosis of cancer
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Concurrently receiving or has previously received chemotherapy and is scheduled for at least 3 additional courses of chemotherapy
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Each course of chemotherapy must be at least 2 weeks in duration
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No concurrent radiotherapy or interferon therapy
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Brief Fatigue Inventory question #3 "fatigue worst" score of 2 or greater 1 week after first chemotherapy course
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- At least 6 months
Hematopoietic
- Not specified
Hepatic
- No uncontrolled anemia
Renal
- Not specified
Cardiovascular
-
No history of clinically significant cardiac disease, including any of the following:
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Unstable angina
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Left ventricular hypertrophy
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Ischemic echocardiogram changes
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Chest pain
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Arrhythmia
-
Other clinically significant manifestations of mitral valve prolapse in association with use of central nervous system stimulants (e.g., caffeine, amphetamines, or methylphenidate)
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No uncontrolled hypertension
Gastrointestinal
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Able to swallow medication
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No narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract
Other
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No severe headaches
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No glaucoma
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No seizure disorder
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No narcolepsy
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No psychotic disorder
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No Tourette's syndrome
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No alcohol or drug abuse
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Not pregnant or nursing
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Fertile patients must use effective barrier contraception during and for at least 1 full menstrual cycle after study completion
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- No concurrent chronic corticosteroids
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Other
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No prior modafinil
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At least 30 days since prior regular use of psychostimulants (e.g., amphetamines, methylphenidate, or pemoline) or monoamine oxidase inhibitors (MAOIs)
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No concurrent alcohol
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Concurrent acetaminophen with codeine or hydrocodone bitartrate allowed
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Concurrent phenytoin allowed
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Concurrent warfarin for anticoagulation and low-dose warfarin (1 mg by mouth daily) for maintenance of venous access devices allowed
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MBCCOP - Gulf Coast | Mobile | Alabama | United States | 36606 |
| 2 | CCOP - Western Regional, Arizona | Phoenix | Arizona | United States | 85006-2726 |
| 3 | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | United States | 95403 |
| 4 | Medical Center of Aurora - South Campus | Aurora | Colorado | United States | 80012-0000 |
| 5 | Boulder Community Hospital | Boulder | Colorado | United States | 80301-9019 |
| 6 | Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado | United States | 80933 |
| 7 | Porter Adventist Hospital | Denver | Colorado | United States | 80210 |
| 8 | St. Joseph Hospital | Denver | Colorado | United States | 80218-1191 |
| 9 | Presbyterian - St. Luke's Medical Center | Denver | Colorado | United States | 80218 |
| 10 | Rocky Mountain Cancer Centers - Denver Rose | Denver | Colorado | United States | 80220 |
| 11 | CCOP - Colorado Cancer Research Program | Denver | Colorado | United States | 80224 |
| 12 | Swedish Medical Center | Englewood | Colorado | United States | 80112 |
| 13 | Sky Ridge Medical Center | Lone Tree | Colorado | United States | 80124 |
| 14 | Rocky Mountain Cancer Centers - Longmont | Longmont | Colorado | United States | 80501 |
| 15 | St. Mary-Corwin Regional Medical Center | Pueblo | Colorado | United States | 81004 |
| 16 | Rocky Mountain Cancer Centers - Thornton | Thornton | Colorado | United States | 80229 |
| 17 | MBCCOP - Hawaii | Honolulu | Hawaii | United States | 96813 |
| 18 | MBCCOP - University of Illinois at Chicago | Chicago | Illinois | United States | 60612-7323 |
| 19 | CCOP - Central Illinois | Decatur | Illinois | United States | 62526 |
| 20 | CCOP - Evanston | Evanston | Illinois | United States | 60201 |
| 21 | CCOP - Wichita | Wichita | Kansas | United States | 67214-3882 |
| 22 | CCOP - Kalamazoo | Kalamazoo | Michigan | United States | 49007-3731 |
| 23 | CCOP - Metro-Minnesota | St. Louis Park | Minnesota | United States | 55416 |
| 24 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
| 25 | CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89106 |
| 26 | CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | United States | 13057 |
| 27 | CCOP - North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 28 | CCOP - Southeast Cancer Control Consortium | Goldsboro | North Carolina | United States | 27534-9479 |
| 29 | CCOP - Columbus | Columbus | Ohio | United States | 43215 |
| 30 | CCOP - Dayton | Dayton | Ohio | United States | 45429 |
| 31 | CCOP - Columbia River Oncology Program | Portland | Oregon | United States | 97225 |
| 32 | CCOP - Greenville | Greenville | South Carolina | United States | 29615 |
| 33 | CCOP - Virginia Mason Research Center | Seattle | Washington | United States | 98101 |
| 34 | CCOP - Northwest | Tacoma | Washington | United States | 98405-0986 |
| 35 | CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | United States | 54449 |
Sponsors and Collaborators
- Gary Morrow
- National Cancer Institute (NCI)
Investigators
- Study Chair: Gary R. Morrow, PhD, MS, James P. Wilmot Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000069477
- U10CA037420
- URCC-U2901