Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors - Full Text View

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 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

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Depression Fatigue

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by Wake Forest University Baptist Medical Center:

Study Start Date:	April 2002
Study Completion Date:	May 2006
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Detailed Description:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031798

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

Sponsors and Collaborators

Wake Forest University Baptist Medical Center

National Cancer Institute (NCI)

Investigators

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 February 09, 2012