Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy
3 other identifiers
interventional
837
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2002
Longer than P75 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 5, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedOctober 15, 2015
October 1, 2015
4.7 years
August 5, 2002
October 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Gary Morrowlead
- National Cancer Institute (NCI)collaborator
Study Sites (35)
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
Medical Center of Aurora - South Campus
Aurora, Colorado, 80012-0000, United States
Boulder Community Hospital
Boulder, Colorado, 80301-9019, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, 80933, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
St. Joseph Hospital
Denver, Colorado, 80218-1191, United States
Presbyterian - St. Luke's Medical Center
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers - Denver Rose
Denver, Colorado, 80220, United States
CCOP - Colorado Cancer Research Program
Denver, Colorado, 80224, United States
Swedish Medical Center
Englewood, Colorado, 80112, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers - Longmont
Longmont, Colorado, 80501, United States
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado, 81004, United States
Rocky Mountain Cancer Centers - Thornton
Thornton, Colorado, 80229, United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323, United States
CCOP - Central Illinois
Decatur, Illinois, 62526, United States
CCOP - Evanston
Evanston, Illinois, 60201, United States
CCOP - Wichita
Wichita, Kansas, 67214-3882, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731, United States
CCOP - Metro-Minnesota
Saint 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 - Virginia Mason Research Center
Seattle, Washington, 98101, United States
CCOP - Northwest
Tacoma, Washington, 98405-0986, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449, United States
Related Publications (1)
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.
PMID: 20564068RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gary R. Morrow, PhD, MS
James P. Wilmot Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- SUPPORTIVE CARE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, URCC NCORP Research Base
Study Record Dates
First Submitted
August 5, 2002
First Posted
January 27, 2003
Study Start
August 1, 2002
Primary Completion
April 1, 2007
Study Completion
October 1, 2007
Last Updated
October 15, 2015
Record last verified: 2015-10