Clinical trial NCT00112515: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive/Functional Effects
Depression
Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: depression
cognitive/functional effects
fatigue
unspecified adult solid tumor, protocol specific
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-06-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

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.

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

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
measure: Fatigue as measured by Brief Fatigue Inventory at 2 and 4 weeks after the start of treatment
Secondary outcomes:
measure: Mood as measured by Hamilton Rating Scale for Depression at 2 and 4 weeks after the start of treatment
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Functional status as measured by Barthel Index and ECOG performance status at 2 and 4 weeks after the start of treatment
measure: Quality of life as measured by Functional Assessment of Cancer Therapy-Br at 2 and 4 weeks after the start of treatment
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center
state: Virginia
Study officials:
affiliation: University of Virginia
name: Leslie Blackhall, MD
role: PRINCIPAL_INVESTIGATOR
References: