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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Terminated

CT.gov ID

NCT00031798

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	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

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

Double

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

Actual Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Mar 1, 2005

Actual Study Completion Date :

May 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Western Regional, Arizona	Phoenix	Arizona	United States	85006-2726
2	CCOP - Central Illinois	Decatur	Illinois	United States	62526
3	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
4	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina	United States	27534-9479
5	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1030
6	CCOP - Columbus	Columbus	Ohio	United States	43206
7	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303