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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00052286 |
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 Cancer-Related Problem/Condition 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 |
Estimated Enrollment: | 30 |
Study Start Date: | September 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, parallel-group study. Patients are randomized to 1 of 2 arms.
Randomized phase:
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.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of primary malignant brain tumor and receiving treatment in the UCLA Neuro-Oncology Program
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-6967 |
Principal Investigator: | Timothy F. Cloughesy, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000258139, UCLA-0206017, CEPHALON-UCLA-0206017, NCI-G02-2133 |
Study First Received: | January 24, 2003 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00052286 |
Health Authority: | United States: Federal Government |
adult brain tumor fatigue cognitive/functional effects |
Signs and Symptoms Brain Neoplasms Fatigue |
Central Nervous System Neoplasms Modafinil Nervous System Neoplasms |
Neoplasms Neoplasms by Site Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Central Nervous System Stimulants Protective Agents Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions |