Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fatigue; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: modafinil (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of Rochester Official(s) and/or principal investigator(s):
Gary R. Morrow, PhD, MS, Study Chair, Affiliation: James P. Wilmot Cancer Center
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.
Clinical Details
Official title: Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy
Study design: Supportive Care, Randomized, Double-Blind, Placebo Control
Primary outcome: Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4
Secondary outcome: 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Concurrently receiving or has previously received chemotherapy and is scheduled for at
least 3 additional courses of chemotherapy
- Each course of chemotherapy must be at least 2 weeks in duration
- No concurrent radiotherapy or interferon therapy
- 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:
- Unstable angina
- Left ventricular hypertrophy
- Ischemic echocardiogram changes
- Chest pain
- Arrhythmia
- Other clinically significant manifestations of mitral valve prolapse in
association with use of CNS stimulants (e. g., caffeine, amphetamines, or
methylphenidate)
- No uncontrolled hypertension
Gastrointestinal
- Able to swallow medication
- No narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal
tract
Other
- No severe headaches
- No glaucoma
- No seizure disorder
- No narcolepsy
- No psychotic disorder
- No Tourette's syndrome
- No alcohol or drug abuse
- Not pregnant or nursing
- 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
- No prior modafinil
- At least 30 days since prior regular use of psychostimulants (e. g., amphetamines,
methylphenidate, or pemoline) or monoamine oxidase inhibitors (MAOIs)
- No concurrent alcohol
- Concurrent acetaminophen with codeine or hydrocodone bitartrate allowed
- Concurrent phenytoin allowed
- Concurrent warfarin for anticoagulation and low-dose warfarin (1 mg by mouth daily)
for maintenance of venous access devices allowed
Locations and Contacts
MBCCOP - Gulf Coast, Mobile, Alabama 36606, United States
CCOP - Western Regional, Arizona, Phoenix, Arizona 85006-2726, United States
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California 95403, United States
Boulder Community Hospital, Boulder, Colorado 80301-9019, United States
CCOP - Colorado Cancer Research Program, Denver, Colorado 80224, United States
Medical Center of Aurora - South Campus, Aurora, Colorado 80012-0000, United States
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado 80933, United States
Porter Adventist Hospital, Denver, Colorado 80210, United States
Presbyterian - St. Luke's Medical Center, Denver, Colorado 80218, United States
Rocky Mountain Cancer Centers - Denver Rose, Denver, Colorado 80220, United States
Rocky Mountain Cancer Centers - Longmont, Longmont, Colorado 80501, United States
Rocky Mountain Cancer Centers - Thornton, Thornton, Colorado 80229, United States
Sky Ridge Medical Center, Lone Tree, Colorado 80124, United States
St. Joseph Hospital, Denver, Colorado 80218-1191, United States
St. Mary-Corwin Regional Medical Center, Pueblo, Colorado 81004, United States
Swedish Medical Center, Englewood, Colorado 80112, United States
MBCCOP - Hawaii, Honolulu, Hawaii 96813, United States
CCOP - Central Illinois, Decatur, Illinois 62526, United States
CCOP - Evanston, Evanston, Illinois 60201, United States
MBCCOP - University of Illinois at Chicago, Chicago, Illinois 60612-7323, United States
CCOP - Wichita, Wichita, Kansas 67214-3882, United States
CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States
CCOP - Metro-Minnesota, St. Louis Park, Minnesota 55416, United States
CCOP - Kansas City, Kansas City, Missouri 64131, United States
CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States
CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York 13057, United States
CCOP - North Shore University Hospital, Manhasset, New York 11030, United States
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina 27534-9479, United States
CCOP - Columbus, Columbus, Ohio 43215, United States
CCOP - Dayton, Dayton, Ohio 45429, United States
CCOP - Columbia River Oncology Program, Portland, Oregon 97225, United States
CCOP - Greenville, Greenville, South Carolina 29615, United States
CCOP - Northwest, Tacoma, Washington 98405-0986, United States
CCOP - Virginia Mason Research Center, Seattle, Washington 98101, United States
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin 54449, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database Featured trial article
Starting date: August 2002
Last updated: May 23, 2008
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