Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
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.
|Brain and Central Nervous System Tumors Cognitive/Functional Effects Depression Fatigue Quality of Life||Drug: methylphenidate hydrochloride Procedure: quality-of-life assessment Radiation: radiation therapy||Phase 3|
|Study Design:||Allocation: Randomized
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Supportive Care
|Official Title:||A Phase III, Double-Blind, Prospective Randomized Clinical Trial of the Effect of D-threo-methylphenidate HCl (d-MPH) on Quality of Life in Brain Tumor Patients Receiving Radiation Therapy|
|Study Start Date:||April 2002|
|Study Completion Date:||May 2006|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
- Determine the effect of d-methylphenidate on fatigue in patients receiving radiotherapy for primary or metastatic brain tumors.
- Determine the effect of this drug on the quality of life of these patients.
- Determine the effect of this drug on depression in these patients.
- Determine the effect of this drug on global neurocognitive function, including attention and concentration, memory, language, visuospatial skills, and executive function, in these patients.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified by tumor type (primary vs metastatic), treatment (radiotherapy vs radiotherapy and chemotherapy), and Karnofsky performance status (70% or 80% vs 90% or 100%). Patients are randomized to one of two treatment arms.
All patients undergo radiotherapy over weeks 1-4.
- Arm I: Patients receive oral d-methylphenidate twice daily on weeks 1-12.
- Arm II: Patients receive oral placebo twice daily on weeks 1-12. In both arms, quality of life is assessed at baseline, at the end of radiotherapy, and at 4, 8, and 12 weeks after radiotherapy.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study within 18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031798
|United States, Arizona|
|CCOP - Western Regional, Arizona|
|Phoenix, Arizona, United States, 85006-2726|
|United States, Illinois|
|CCOP - Central Illinois|
|Decatur, Illinois, United States, 62526|
|United States, Louisiana|
|MBCCOP - LSU Health Sciences Center|
|New Orleans, Louisiana, United States, 70112|
|United States, North Carolina|
|CCOP - Southeast Cancer Control Consortium|
|Goldsboro, North Carolina, United States, 27534-9479|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157-1030|
|United States, Ohio|
|CCOP - Columbus|
|Columbus, Ohio, United States, 43206|
|United States, South Carolina|
|CCOP - Upstate Carolina|
|Spartanburg, South Carolina, United States, 29303|
|Study Chair:||Edward G. Shaw, MD||Wake Forest University Health Sciences|