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Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00031798
Recruitment Status : Terminated (low accrual; loss of funding)
First Posted : January 27, 2003
Last Update Posted : August 13, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief 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.

Condition or disease Intervention/treatment 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 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
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
Actual Primary Completion Date : March 2005
Actual Study Completion Date : May 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed metastatic brain tumor OR
  • Histologically confirmed primary brain tumor

    • Glioblastoma multiforme
    • Anaplastic astrocytoma
    • Anaplastic oligodendroglioma
    • Anaplastic mixed oligoastrocytoma
    • Low-grade glioma
    • Meningioma
    • Ependymoma
  • Planned external beam cranial radiotherapy (partial or whole brain) with a total dose of at least 25 Gy in at least 10 fractions of 180-300 cGy each



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months


  • WBC ≥ 1,500/mm^3
  • Hemoglobin ≥ 10.0 g/dL
  • Platelet count ≥ 75,000/mm^3


  • Not specified


  • Not specified


  • No hypertension or other cardiovascular disease requiring antihypertensives and/or other cardiovascular medications


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other serious medical or psychiatric illness that would preclude study participation
  • No hypersensitivity to study drug
  • No history of steroid psychosis
  • No family history of or active Tourette's Syndrome
  • No prior or active glaucoma


Biologic therapy:

  • Not specified


  • Prior or concurrent chemotherapy allowed

Endocrine therapy:

  • Concurrent steroids allowed


  • See Disease Characteristics
  • Prior radiotherapy allowed except to brain (including stereotactic radiosurgery)
  • No concurrent craniospinal axis radiotherapy


  • Not specified


  • No prior or concurrent medications for attention deficit disorder, anxiety disorder, schizophrenia, or substance abuse
  • No concurrent anti-depressants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00031798

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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
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
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Study Chair: Edward G. Shaw, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences Identifier: NCT00031798    
Other Study ID Numbers: REBACDR0000069227
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
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
Additional relevant MeSH terms:
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Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Behavioral Symptoms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents