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

Sponsor:	University of California, Los Angeles
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of California, Los Angeles
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:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care
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 Fatigue

Drug Information available for: Modafinil

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Neurocognitive functioning as assessed by Trail Making Test, Symbol Digit Modalities Test, and Verbal Fluency. [ Time Frame: at baseline and weeks 1, 3, 4, 8, and 10 ] [ Designated as safety issue: No ]
Mood as assessed by Hamilton Depression Scale (31 questions). [ Time Frame: at baseline and weeks 3, 4, 8, and 10 ] [ Designated as safety issue: No ]
Fatigue level as assessed by Fatigue Severity Scale, Modified Fatigue Impact Scale, and Visual Analogue Fatigue Scale [ Time Frame: at baseline and weeks 1, 3, 4, 5, 7, 8, 9, and 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Global functioning as assessed by Clinical Global Impression of Severity and Clinical Global Impression of Change. [ Time Frame: at baseline and weeks 1, 3, 4, 5, 7, 8, 9, and 10 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2002
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

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

Inclusion Criteria:

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
Age 21 to 65
Able to speak English
Capable of completing self-rating scales and one-on-one psychometric tests
Negative pregnancy test
Fertile patients must use effective contraception
Concurrent conventional chemotherapy (e.g., carboplatin, lomustine, temozolomide) allowed
Concurrent glucocorticoids (e.g., dexamethasone) allowed
Concurrent tamoxifen allowed
At least 30 days since prior stimulants (e.g., amphetamines or methylphenidate)
Concurrent anticonvulsants allowed
Concurrent isotretinoin allowed

Exclusion Criteria:

Have significant hepatic disease, defined as SGOT greater than or equal to 2.5 times the upper limit of normal.
Have significant renal disease, defined as creatinine greater than or equal to 1.5mg/dl.
severe cognitive impairment
other terminal illness
emergency patient
institutional resident
prisoner or parolee
UCLA students or staff
pregnant or nursing
concurrent irinotecan
concurrent participation in UCLA experimental chemotherapy trials
prior modafinil
concurrent experimental anticancer medication
concurrent tricyclic antidepressants and/or monoamine oxidase inhibitors

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

University of California, Los Angeles

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

Responsible Party:	Timothy Cloughesy, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00052286 History of Changes
Other Study ID Numbers:	CDR0000258139, P30CA016042, UCLA-0206017, CEPHALON-UCLA-0206017, NCI-G02-2133
Study First Received:	January 24, 2003
Last Updated:	June 17, 2011
Health Authority:	United States: Federal Government

Keywords provided by University of California, Los Angeles:

adult brain tumor
fatigue
cognitive/functional effects

Additional relevant MeSH terms:

Fatigue
Nervous System Neoplasms
Central Nervous System Neoplasms
Signs and Symptoms
Neoplasms by Site
Neoplasms
Nervous System Diseases
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 09, 2012