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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
  Purpose

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.


Condition Intervention Phase
Fatigue Unspecified Adult Solid Tumor, Protocol Specific Drug: modafinil Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Official Title: Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Further study details as provided by Gary Morrow, University of Rochester NCORP Research Base:

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
Estimated Enrollment: 837
Study Start Date: August 2002
Study Completion Date: October 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042848


  Show 35 Study Locations
Sponsors and Collaborators
Gary Morrow
National Cancer Institute (NCI)
Investigators
Study Chair: Gary R. Morrow, PhD, MS James P. Wilmot Cancer Center
  More Information

Publications:

Responsible Party: Gary Morrow, Director, URCC NCORP Research Base, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT00042848     History of Changes
Other Study ID Numbers: CDR0000069477
U10CA037420 ( U.S. NIH Grant/Contract )
URCC-U2901 ( Other Identifier: University of Rochester )
First Submitted: August 5, 2002
First Posted: January 27, 2003
Last Update Posted: October 15, 2015
Last Verified: October 2015

Keywords provided by Gary Morrow, University of Rochester NCORP Research Base:
fatigue
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Modafinil
Armodafinil
Wakefulness-Promoting Agents
 Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs