Modafinil in Treating Fatigue in Patients With Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Modafinil may help relieve fatigue and improve quality of life in patients with cancer.

PURPOSE: This clinical trial is studying how well modafinil works in treating fatigue in patients with cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Collaborator: National Cancer Institute (NCI)
• Treatments: Armodafinil; Modafinil

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of cancer

• Brief Fatigue Inventory score ≥ 4

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 1-3

Life expectancy

• At least 2 months

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• No history of left ventricular hypertrophy

• No history of ischemic ECG changes

• No history of chest pain

• No history of arrhythmia

• No history of other clinically significant manifestations of mitral valve prolapse in association with CNS stimulant use

Other

• Not pregnant or nursing

• Negative pregnancy test

• Thyroid stimulating hormone normal

• No known hypersensitivity to modafinil

• No history of psychotic disorder and/or active psychosis

• No history of any chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation or compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Concurrent thalidomide allowed

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Concurrent narcotics, phenothiazines, or benzodiazepines allowed

• No other concurrent investigational therapy