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Modafinil in Treating Fatigue in Patients With Cancer

Primary Purpose

Cognitive/Functional Effects, Depression, Fatigue

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
modafinil
cognitive assessment
psychosocial assessment and care
quality-of-life assessment
Sponsored by
University of Virginia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cognitive/Functional Effects focused on measuring depression, cognitive/functional effects, fatigue, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia Cancer Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 2, 2005
Last Updated
August 19, 2009
Sponsor
University of Virginia
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00112515
Brief Title
Modafinil in Treating Fatigue in Patients With Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Unknown status
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Virginia
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive/Functional Effects, Depression, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
depression, cognitive/functional effects, fatigue, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
modafinil
Intervention Type
Procedure
Intervention Name(s)
cognitive assessment
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
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
Title
Fatigue as measured by Brief Fatigue Inventory at 2 and 4 weeks after the start of treatment
Secondary Outcome Measure Information:
Title
Mood as measured by Hamilton Rating Scale for Depression at 2 and 4 weeks after the start of treatment
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Functional status as measured by Barthel Index and ECOG performance status at 2 and 4 weeks after the start of treatment
Title
Quality of life as measured by Functional Assessment of Cancer Therapy-Br at 2 and 4 weeks after the start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Blackhall, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

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Modafinil in Treating Fatigue in Patients With Cancer

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