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| Sponsor: | Wake Forest University Baptist Medical Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Wake Forest University Baptist Medical Center |
| ClinicalTrials.gov Identifier: | NCT00031798 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Placebo Control Masking: Double-Blind 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) |
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary brain tumor
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Edward G. Shaw, MD ( principal investigator ) |
| Study ID Numbers: | CDR0000069227, CCCWFU-97600, NCI-P02-0211 |
| Study First Received: | March 8, 2002 |
| Last Updated: | August 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00031798 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
fatigue depression quality of life cognitive/functional effects recurrent adult brain tumor adult brain stem glioma adult glioblastoma adult tumors metastatic to brain adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult mixed glioma |
adult meningioma adult anaplastic ependymoma adult myxopapillary ependymoma adult ependymoblastoma adult pilocytic astrocytoma adult subependymoma adult grade III meningioma adult giant cell glioblastoma adult gliosarcoma adult grade II meningioma |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Methylphenidate Central Nervous System Neoplasms Brain Diseases Signs and Symptoms Neoplasms by Site Mental Disorders Therapeutic Uses Nervous System Neoplasms |
Fatigue Depression Nervous System Diseases Central Nervous System Diseases Central Nervous System Stimulants Depressive Disorder Pharmacologic Actions Behavioral Symptoms Brain Neoplasms Neoplasms Mood Disorders Dopamine Agents Central Nervous System Agents |