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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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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

Conditions
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Fatigue, Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Depression, Quality of Life

Intervention / Treatment
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* Drug: methylphenidate hydrochloride
* Procedure: quality-of-life assessment
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: WBC ≥ 1,500/mm^3 Hemoglobin ≥ 10.0 g/dL Platelet count ≥ 75,000/mm^3 Hepatic: Not specified Renal: Not specified Cardiovascular: No hypertension or other cardiovascular disease requiring antihypertensives and/or other cardiovascular medications Other: 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 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior or concurrent chemotherapy allowed Endocrine therapy: Concurrent steroids allowed Radiotherapy: See Disease Characteristics Prior radiotherapy allowed except to brain (including stereotactic radiosurgery) No concurrent craniospinal axis radiotherapy Surgery: Not specified Other: No prior or concurrent medications for attention deficit disorder, anxiety disorder, schizophrenia, or substance abuse No concurrent anti-depressants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: methylphenidate hydrochloride|nan|
|Procedure: quality-of-life assessment|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive/functional effects, fatigue, depression, quality of life, 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