Back to resultsModafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
Primary Purpose
Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
modafinil
Sponsored by
About this trial
This is an interventional supportive care trial for Fatigue focused on measuring fatigue, unspecified adult solid tumor, protocol specific
Eligibility 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 central nervous system 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
Sites / Locations
- MBCCOP - Gulf Coast
- CCOP - Western Regional, Arizona
- CCOP - Santa Rosa Memorial Hospital
- Medical Center of Aurora - South Campus
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- Porter Adventist Hospital
- St. Joseph Hospital
- Presbyterian - St. Luke's Medical Center
- Rocky Mountain Cancer Centers - Denver Rose
- CCOP - Colorado Cancer Research Program
- Swedish Medical Center
- Sky Ridge Medical Center
- Rocky Mountain Cancer Centers - Longmont
- St. Mary-Corwin Regional Medical Center
- Rocky Mountain Cancer Centers - Thornton
- MBCCOP - Hawaii
- MBCCOP - University of Illinois at Chicago
- CCOP - Central Illinois
- CCOP - Evanston
- CCOP - Wichita
- CCOP - Kalamazoo
- CCOP - Metro-Minnesota
- CCOP - Kansas City
- CCOP - Nevada Cancer Research Foundation
- CCOP - Hematology-Oncology Associates of Central New York
- CCOP - North Shore University Hospital
- CCOP - Southeast Cancer Control Consortium
- CCOP - Columbus
- CCOP - Dayton
- CCOP - Columbia River Oncology Program
- CCOP - Greenville
- CCOP - Virginia Mason Research Center
- CCOP - Northwest
- CCOP - Marshfield Clinic Research Foundation
Outcomes
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
Full Information
NCT ID
NCT00042848
First Posted
August 5, 2002
Last Updated
October 13, 2015
Sponsor
Gary Morrow
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00042848
Brief Title
Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
Official Title
Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gary Morrow
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
fatigue, unspecified adult solid tumor, protocol specific
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
837 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
modafinil
Primary Outcome Measure Information:
Title
Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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 central nervous system 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary R. Morrow, PhD, MS
Organizational Affiliation
James P. Wilmot Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
MBCCOP - Gulf Coast
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36606
Country
United States
Facility Name
CCOP - Western Regional, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2726
Country
United States
Facility Name
CCOP - Santa Rosa Memorial Hospital
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Medical Center of Aurora - South Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012-0000
Country
United States
Facility Name
Boulder Community Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301-9019
Country
United States
Facility Name
Penrose Cancer Center at Penrose Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80933
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
St. Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218-1191
Country
United States
Facility Name
Presbyterian - St. Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Denver Rose
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
CCOP - Colorado Cancer Research Program
City
Denver
State/Province
Colorado
ZIP/Postal Code
80224
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Sky Ridge Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Longmont
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
St. Mary-Corwin Regional Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Thornton
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
MBCCOP - Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
MBCCOP - University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7323
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
CCOP - Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
CCOP - Hematology-Oncology Associates of Central New York
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
CCOP - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-9479
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
CCOP - Virginia Mason Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
CCOP - Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-0986
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20564068
Citation
Jean-Pierre P, Morrow GR, Roscoe JA, Heckler C, Mohile S, Janelsins M, Peppone L, Hemstad A, Esparaz BT, Hopkins JO. A phase 3 randomized, placebo-controlled, double-blind, clinical trial of the effect of modafinil on cancer-related fatigue among 631 patients receiving chemotherapy: a University of Rochester Cancer Center Community Clinical Oncology Program Research base study. Cancer. 2010 Jul 15;116(14):3513-20. doi: 10.1002/cncr.25083.
Results Reference
result
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Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
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