Overview

This trial is active, not recruiting.

Conditions cognitive/functional effects, depression, fatigue, unspecified adult solid tumor, protocol specific
Treatments modafinil, cognitive assessment, psychosocial assessment and care, quality-of-life assessment
Sponsor University of Virginia
Collaborator National Cancer Institute (NCI)
Start date February 2004
Trial identifier NCT00112515, CDR0000432953, UVACC-30603, UVACC-HIC-10951

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose supportive care

Primary Outcomes

Measure
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
time frame:
Fatigue as measured by Brief Fatigue Inventory at 2 and 4 weeks after the start of treatment
time frame:

Secondary Outcomes

Measure
Mood as measured by Hamilton Rating Scale for Depression at 2 and 4 weeks after the start of treatment
time frame:
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
time frame:
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
time frame:
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
time frame:
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
time frame:
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
time frame:
Functional status as measured by Barthel Index and ECOG performance status at 2 and 4 weeks after the start of treatment
time frame:
Quality of life as measured by Functional Assessment of Cancer Therapy-Br at 2 and 4 weeks after the start of treatment
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Leslie Blackhall, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).