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Pilot Study Evaluating the Safety and Efficacy of Modafinil in Improving Fatigue, Mood, Cognitive Ability, Functional Status, and Quality of Life of Cancer Patients


N/A
18 Years
N/A
Open (Enrolling)
Both
Cognitive/Functional Effects, Depression, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Pilot Study Evaluating the Safety and Efficacy of Modafinil in Improving Fatigue, Mood, Cognitive Ability, Functional Status, and Quality of Life of Cancer Patients


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Outcome 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

Principal Investigator

Leslie Blackhall, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Federal Government

Study ID:

CDR0000432953

NCT ID:

NCT00112515

Start Date:

February 2004

Completion Date:

Related Keywords:

  • Cognitive/Functional Effects
  • Depression
  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific
  • depression
  • cognitive/functional effects
  • fatigue
  • unspecified adult solid tumor, protocol specific
  • Depression
  • Depressive Disorder
  • Fatigue

Name

Location

University of Virginia Cancer CenterCharlottesville, Virginia  22908