Modafinil in Treating Fatigue in Patients With Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00112515
First received: June 2, 2005
Last updated: August 19, 2009
Last verified: May 2006
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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

Study Start Date: February 2004
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112515

Locations
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Leslie Blackhall, MD University of Virginia
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00112515     History of Changes
Other Study ID Numbers: CDR0000432953, UVACC-HIC-10951, UVACC-30603
Study First Received: June 2, 2005
Last Updated: August 19, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
depression
cognitive/functional effects
fatigue
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Depression
Depressive Disorder
Fatigue
Behavioral Symptoms
Mood Disorders
Mental Disorders
Signs and Symptoms
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 29, 2014