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

NCT ID: NCT00031798

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-01
• Study Completion Date: 2006-05-01

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.

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.

Conditions

Brain and Central Nervous System Tumors; Cognitive/Functional Effects; Depression; Fatigue; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Interventions

methylphenidate hydrochloride

Intervention Type: DRUG

quality-of-life assessment

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward G. Shaw, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

CCOP - Western Regional, Arizona

Phoenix, Arizona, United States

CCOP - Central Illinois

Decatur, Illinois, United States

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, United States

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, United States

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, United States

CCOP - Columbus

Columbus, Ohio, United States

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Countries

United States

Other Identifiers

CCCWFU-97600

Identifier Type: -

Identifier Source: secondary_id

NCI-P02-0211

Identifier Type: -

Identifier Source: secondary_id

REBACDR0000069227

Identifier Type: -

Identifier Source: org_study_id