Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer

Completed · Not applicable

Conditions studied: Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Fatigue

In brief

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.

Key facts

Study ID

NCT00052286

Run by

Jonsson Comprehensive Cancer Center

People needed

29

Starts

2002-09-01

Expected to finish

2010-08-01

Last updated by the study team

2020-08-03

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Jonsson Comprehensive Cancer Center at UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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