Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

837 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fatigue Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Interventions

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modafinil

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Gary Morrow

Director, URCC NCORP Research Base

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gary R. Morrow, PhD, MS

Role: STUDY_CHAIR

James P. Wilmot Cancer Center

Locations

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MBCCOP - Gulf Coast

Mobile, Alabama, United States

Site Status

CCOP - Western Regional, Arizona

Phoenix, Arizona, United States

Site Status

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, United States

Site Status

Medical Center of Aurora - South Campus

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status