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Modafinil in Treating Fatigue in Patients With Cancer

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ClinicalTrials.gov Identifier: NCT00112515
Recruitment Status : Unknown
Verified May 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : June 3, 2005
Last Update Posted : August 20, 2009
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

June 2, 2005
June 3, 2005
August 20, 2009
February 2004
Not Provided
  • 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
Not Provided
Complete list of historical versions of study NCT00112515 on ClinicalTrials.gov Archive Site
  • 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
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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

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

  • 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.

Interventional
Not Applicable
Primary Purpose: Supportive Care
  • Cognitive/Functional Effects
  • Depression
  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: modafinil
  • Procedure: cognitive assessment
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00112515
CDR0000432953
UVACC-HIC-10951
UVACC-30603
Not Provided
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University of Virginia
National Cancer Institute (NCI)
Principal Investigator: Leslie Blackhall, MD University of Virginia
National Cancer Institute (NCI)
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP