Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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 | Comprehensive Cancer Center of Wake Forest University |
More Information
No publications provided
| Responsible Party: | principal investigator, Edward G. Shaw, MD |
| ClinicalTrials.gov Identifier: | NCT00031798 History of Changes |
| Other Study ID Numbers: | CDR0000069227, CCCWFU-97600, NCI-P02-0211 |
| Study First Received: | March 8, 2002 |
| Last Updated: | August 20, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Wake Forest University Baptist Medical Center:
|
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 |
Additional relevant MeSH terms:
|
Brain Neoplasms Depression Depressive Disorder Fatigue Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Behavioral Symptoms Mood Disorders |
Mental Disorders Signs and Symptoms Methylphenidate Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013