Overview

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