Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gary Morrow
• Collaborator: National Cancer Institute (NCI)
• Treatments: Armodafinil; Modafinil

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