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Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy

Phase 3
18 Years
Not Enrolling
Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy


- Assess the degree to which modafinil can reduce fatigue in cancer patients receiving

- Assess the relationship between depression and fatigue in patients treated with this

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.

Inclusion Criteria


- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4

Principal Investigator

Gary R. Morrow, PhD, MS

Investigator Role:

Study Chair

Investigator Affiliation:

James P. Wilmot Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 2002

Completion Date:

October 2007

Related Keywords:

  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific
  • fatigue
  • unspecified adult solid tumor, protocol specific
  • Fatigue



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