Modafinil in Treating Fatigue in Patients With Cancer

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Cognitive/Functional Effects
Depression
Fatigue
Unspecified Adult Solid Tumor, Protocol Specific

Clinical Trial Details

NCT number	NCT00112515
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Active, not recruiting
Phase	N/A
Start date	February 2004

View Details

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