Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain and Central Nervous System Tumors; Cognitive/Functional Effects; Depression; Fatigue; Quality of Life
Intervention: methylphenidate hydrochloride (Drug); quality-of-life assessment (Procedure); radiation therapy (Procedure)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Wake Forest University Official(s) and/or principal investigator(s):
Edward G. Shaw, MD, Study Chair, Affiliation: Wake Forest University
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.
Clinical Details
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 design: Supportive Care, Randomized, Double-Blind, Placebo Control
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
CCOP - Western Regional, Arizona, Phoenix, Arizona 85006-2726, United States
CCOP - Central Illinois, Decatur, Illinois 62526, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana 70112, United States
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina 27534-9479, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina 27157-1030, United States
CCOP - Columbus, Columbus, Ohio 43206, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: April 2002
Last updated: May 23, 2008
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