Modafinil in Treating Fatigue in Patients With Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cognitive/Functional Effects; Depression; Fatigue; Quality of Life; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: modafinil (Drug); cognitive assessment (Procedure); psychosocial assessment and care (Procedure); quality-of-life assessment (Procedure)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Virginia Official(s) and/or principal investigator(s):
Leslie Blackhall, MD, Principal Investigator, Affiliation: University of Virginia
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 Details
Official title: Pilot Study Evaluating the Safety and Efficacy of Modafinil in Improving Fatigue, Mood, Cognitive Ability, Functional Status, and Quality of Life of Cancer Patients
Study design: Supportive Care
Primary outcome: 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 treatmentFatigue as measured by Brief Fatigue Inventory at 2 and 4 weeks after the start of treatment
Secondary outcome: Mood as measured by Hamilton Rating Scale for Depression at 2 and 4 weeks after the start of treatmentCognitive 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University of Virginia Cancer Center, Charlottesville, Virginia 22908, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: February 2004
Last updated: May 23, 2008
|
