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Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00042848
First Posted: January 27, 2003
Last Update Posted: October 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base
August 5, 2002
January 27, 2003
October 15, 2015
August 2002
April 2007   (Final data collection date for primary outcome measure)
Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4
Not Provided
Complete list of historical versions of study NCT00042848 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 3
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: modafinil
Not Provided
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.
 
Completed
837
October 2007
April 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00042848
CDR0000069477
U10CA037420 ( U.S. NIH Grant/Contract )
URCC-U2901 ( Other Identifier: University of Rochester )
Yes
Not Provided
Not Provided
Gary Morrow, University of Rochester NCORP Research Base
Gary Morrow
National Cancer Institute (NCI)
Study Chair: Gary R. Morrow, PhD, MS James P. Wilmot Cancer Center
University of Rochester
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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