Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
NCT00031798 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2021-09-09
Summary
RATIONALE: Methylphenidate may decrease side effects of radiation therapy. It is not yet known if methylphenidate is effective in improving quality of life in patients with primary or metastatic brain tumors.
PURPOSE: Randomized phase III trial to determine the effectiveness of methylphenidate in improving quality of life in patients who have brain tumors and are undergoing radiation therapy.
Conditions
- Brain and Central Nervous System Tumors
- Cognitive/Functional Effects
- Depression
- Fatigue
- Quality of Life
Interventions
- DRUG
-
methylphenidate hydrochloride
- PROCEDURE
-
quality-of-life assessment
- RADIATION
-
radiation therapy
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Wake Forest University Health Sciences
lead OTHER
Principal Investigators
-
Edward G. Shaw, MD · Wake Forest University Health Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
Eligibility
- Min Age
- 18 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-04-01
- Primary Completion
- 2005-03-01
- Completion
- 2006-05-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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