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
- 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
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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Edward G. Shaw, MD
Comprehensive Cancer Center of Wake Forest University
United States: Food and Drug Administration
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Columbus||Columbus, Ohio 43206|
|CCOP - Western Regional, Arizona||Phoenix, Arizona 85006-2726|
|MBCCOP - LSU Health Sciences Center||New Orleans, Louisiana 70112|