Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

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

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.

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