Modafinil in Treating Fatigue in Patients With Cancer

University of Virginia

Status

Unknown

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Depression

Fatigue

Cognitive/Functional Effects

Treatments

Procedure: quality-of-life assessment

Drug: modafinil

Procedure: cognitive assessment

Procedure: psychosocial assessment and care

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00112515

CDR0000432953

UVACC-30603

UVACC-HIC-10951

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

Determine the safety of modafinil in cancer patients.
Determine the efficacy of this drug, in terms of improving fatigue, in these patients.

Secondary

Determine the efficacy of this drug, in terms of improving mood, cognitive ability, functional status, and quality of life, in these patients.

OUTLINE: This is a nonrandomized, pilot study.

Patients receive oral modafinil once daily for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive additional modafinil at the discretion of the physician.

Fatigue, mood, cognition, functional status, and quality of life are assessed at baseline and in weeks 2 and 4.

After completion of study treatment, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study within 9 months.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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