Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base Identifier:
First received: August 5, 2002
Last updated: October 13, 2015
Last verified: October 2015

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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
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:

Further study details as provided by University of Rochester:

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:


  • 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.


Ages Eligible for Study:   18 Years to 120 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • At least 6 months


  • Not specified


  • No uncontrolled anemia


  • Not specified


  • 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


  • Able to swallow medication
  • No narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract


  • 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


Biologic therapy

  • See Disease Characteristics


  • See Disease Characteristics

Endocrine therapy

  • No concurrent chronic corticosteroids


  • See Disease Characteristics


  • Not specified


  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00042848

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

Additional Information:
Responsible Party: Gary Morrow, Director, URCC NCORP Research Base, University of Rochester NCORP Research Base Identifier: NCT00042848     History of Changes
Other Study ID Numbers: CDR0000069477, U10CA037420, URCC-U2901
Study First Received: August 5, 2002
Last Updated: October 13, 2015
Health Authority: United States: Federal Government

Keywords provided by University of Rochester:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Signs and Symptoms
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Wakefulness-Promoting Agents processed this record on November 25, 2015