Modafinil in Treating Fatigue in Patients With Cancer - Full Text View

Sponsor:	University of Virginia
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00112515

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:

MedlinePlus related topics: Cancer Depression Fatigue

Drug Information available for: Modafinil

U.S. FDA Resources

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

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

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Leslie Blackhall, MD

University of Virginia

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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 February 12, 2012