An interventional study of modafinil and cognitive assessment in Cognitive/Functional Effects, Depression and Fatigue, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-08-20.
Sponsored by University of Virginia · Not applicable, Interventional, and Supportive care
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.
OBJECTIVES:
Primary
Secondary
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.
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
Browse Depression studies →University of Virginia is the lead sponsor of 672 studies on the registry; 138 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Safety, in terms of adverse events and dose-limiting toxicity, as measured by NCI CTC v2.0 at up to 4 weeks after the start of treatment
Fatigue as measured by Brief Fatigue Inventory at 2 and 4 weeks after the start of treatment
Mood as measured by Hamilton Rating Scale for Depression at 2 and 4 weeks after the start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Hopkins Verbal Learning Test at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Grooved Pegboard Test at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Controlled Oral Word Association Test from the Multilingual Aphasia Examination at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Trail Making Test A and B at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Recall and Recognition of Word List encoded from the Hopkins Verbal Learning Test at 2 and 4 weeks after start of treatment
Functional status as measured by Barthel Index and ECOG performance status at 2 and 4 weeks after the start of treatment
Quality of life as measured by Functional Assessment of Cancer Therapy-Br at 2 and 4 weeks after the start of treatment
This study is status unknown, as verified in May 2006. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Modafinil