Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over	NCI	URCC-U2901 NCI-5952, NCI-P02-0228, NCT00042848

Objectives

1. Assess the degree to which modafinil can reduce fatigue in cancer patients receiving chemotherapy.
2. Assess the relationship between depression and fatigue in patients treated with this drug.

Entry 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

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

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 CNS 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

Expected Enrollment

A total of 837 patients will be accrued for this study within approximately 2.5 years.

Outcomes

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

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

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.

Trial Contact Information

Trial Lead Organizations

University of Rochester Cancer Center CCOP Research Base

Gary Morrow, PhD, MS, Protocol chair		Ph: 585-275-5513

Related Information

Featured trial article

Registry Information
Official Title		Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy
Trial Start Date		2002-08-05
Trial Completion Date		2007-10-01
Registered in ClinicalTrials.gov		NCT00042848
Date Submitted to PDQ		2002-06-03
Information Last Verified		2007-05-06
NCI Grant/Contract Number		CA037420

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