Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer - Full Text View

Sponsor:	Jonsson Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00052286

Purpose

RATIONALE: Modafinil may be effective in relieving fatigue and improving behavioral changes such as memory loss in patients who have undergone treatment for primary brain cancer. The effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet known.

PURPOSE: This randomized clinical trial is comparing how well two different doses of modafinil work in treating fatigue and behavioral changes in patients who have undergone treatment for primary brain cancer.

Condition	Intervention
Brain and Central Nervous System Tumors Cognitive/Functional Effects Fatigue	Drug: modafinil

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Active Control
Official Title:	A Pilot Study of Modafinil for Treatment of Fatigue and Neurobehavioral Dysfunction in Adult Brain Tumor Patients

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

Drug Information available for: Modafinil

U.S. FDA Resources

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

Primary Outcome Measures:

Neurocognitive functioning as assessed by Trail Making Test, Symbol Digit Modalities Test, and Verbal Fluency at baseline and weeks 1, 3, 4, 8, and 10
Mood as assessed by Hamilton Depression Scale (31 questions) at baseline and weeks 3, 4, 8, and 10
Fatigue level as assessed by Fatigue Severity Scale, Modified Fatigue Impact Scale, and Visual Analogue Fatigue Scale at baseline and weeks 1, 3, 4, 5, 7, 8, 9, and 10

Secondary Outcome Measures:

Global functioning as assessed by Clinical Global Impression of Severity and Clinical Global Impression of Change at baseline and weeks 1, 3, 4, 5, 7, 8, 9, and 10

Estimated Enrollment:	30
Study Start Date:	September 2002

Detailed Description:

OBJECTIVES:

Compare the effectiveness of low-dose vs high-dose modafinil for treatment of fatigue and neurobehavioral dysfunction in patients with primary brain tumors.
Determine the safety of this drug in these patients.
Compare quality of life of patients treated with 2 different doses of this drug.

OUTLINE: This is a randomized, double-blind, parallel-group study. Patients are randomized to 1 of 2 arms.

Randomized phase:
- Arm I: Patients receive oral high-dose modafinil twice daily.
- Arm II: Patients receive oral low-dose modafinil twice daily. In both arms, treatment in this phase continues for 3 weeks followed by a 1-week washout period.
Extended treatment phase:After the 1-week washout period, all patients receive oral low-dose modafinil once daily on days 1-3. The dose is then titrated to an optimal level and administered in divided doses.

Fatigue, neurobehavioral dysfunction, and quality of life are assessed during the randomized phase at baseline and on days 7 and 21 and then during the extended treatment phase at baseline and on days 28 and 56.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of primary malignant brain tumor and receiving treatment in the UCLA Neuro-Oncology Program
- Nonmalignant cerebral tumors also allowed
Received some combination of prior therapy for disease, including neurosurgical resection, radiotherapy, and cytotoxic or cytostatic chemotherapy
Mild to severe fatigue and/or attention/memory impairment, as measured by the Clinical Global Impression of Severity Scale

PATIENT CHARACTERISTICS:

Age

21 to 65

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Bilirubin no greater than 2.5 times normal
SGOT no greater than 2.5 times normal

Renal

Creatinine no greater than 1.5 mg/dL

Other

Able to speak English
Capable of completing self-rating scales and one-on-one psychometric tests
No severe cognitive impairment
No other terminal illness
No emergency patients
No institutional residents
No prisoners or parolees
No UCLA students or staff
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics
No concurrent irinotecan
No concurrent participation in UCLA experimental chemotherapy trials
Concurrent conventional chemotherapy (e.g., carboplatin, lomustine, temozolomide) allowed

Endocrine therapy

Concurrent glucocorticoids (e.g., dexamethasone) allowed
Concurrent tamoxifen allowed

Radiotherapy

See Disease Characteristics

Surgery

See Disease Characteristics

Other

No prior modafinil
At least 30 days since prior stimulants (e.g., amphetamines or methylphenidate)
No concurrent experimental anticancer medication
No concurrent tricyclic antidepressants and/or monoamine oxidase inhibitors
Concurrent anticonvulsants allowed
Concurrent isotretinoin allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052286

Locations

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-6967

Sponsors and Collaborators

Jonsson Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Timothy F. Cloughesy, MD

Jonsson Comprehensive Cancer Center

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

Study ID Numbers:	CDR0000258139, UCLA-0206017, CEPHALON-UCLA-0206017, NCI-G02-2133
Study First Received:	January 24, 2003
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00052286 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult brain tumor
fatigue
cognitive/functional effects

Additional relevant MeSH terms:

Fatigue
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Neoplasms
Protective Agents
Neuroprotective Agents
Modafinil

Pharmacologic Actions
Signs and Symptoms
Neoplasms
Neoplasms by Site
Therapeutic Uses
Central Nervous System Agents
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 25, 2009