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

This study has been terminated.
(low accrual; loss of funding)
Sponsor:
Collaborator:
Information provided by:
Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT00031798
First received: March 8, 2002
Last updated: August 20, 2009
Last verified: August 2009
  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

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Baptist Health
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 Baptist Health:
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
Central Nervous System Neoplasms
Depression
Depressive Disorder
Fatigue
Neoplasms
Nervous System Neoplasms
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Mood Disorders
Neoplasms by Site
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014