NCT00112515

Modafinil in Treating Fatigue in Patients With Cancer

Pilot Study Evaluating the Safety and Efficacy of Modafinil in Improving Fatigue, Mood, Cognitive Ability, Functional Status, and Quality of Life of Cancer Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	modafinil
PROCEDURE	cognitive assessment
PROCEDURE	psychosocial assessment and care
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2004-02-01
• First posted: 2005-06-03
• Last updated: 2009-08-20

Locations

1 site across 1 country: United States