Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

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.

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 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