Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

Tracking Information
First Submitted Date ICMJE	August 5, 2002
First Posted Date ICMJE	January 27, 2003
Last Update Posted Date	October 15, 2015
Study Start Date ICMJE	August 2002
Actual Primary Completion Date	April 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 8, 2006)	Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00042848 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 8, 2006)	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
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
Official Title ICMJE	Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy
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.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Masking: Double; Primary Purpose: Supportive Care
Condition ICMJE	Fatigue; Unspecified Adult Solid Tumor, Protocol Specific
Intervention ICMJE	Drug: modafinil
Study Arms	Not Provided
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: November 8, 2006)	837
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	October 2007
Actual Primary Completion Date	April 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 120 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00042848
Other Study ID Numbers ICMJE	CDR0000069477; U10CA037420 ( U.S. NIH Grant/Contract ); URCC-U2901 ( Other Identifier: University of Rochester )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Gary Morrow, University of Rochester NCORP Research Base
Study Sponsor ICMJE	Gary Morrow
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Study Chair: Gary R. Morrow, PhD, MS James P. Wilmot Cancer Center
PRS Account	University of Rochester
Verification Date	October 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP