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

Primary Purpose

Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Depression

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
methylphenidate hydrochloride
quality-of-life assessment
radiation therapy
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CCOP - Western Regional, Arizona
  • CCOP - Central Illinois
  • MBCCOP - LSU Health Sciences Center
  • CCOP - Southeast Cancer Control Consortium
  • Comprehensive Cancer Center at Wake Forest University
  • CCOP - Columbus
  • CCOP - Upstate Carolina

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 8, 2002
Last Updated
September 7, 2021
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00031798
Brief Title
Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
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 Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
low accrual; loss of funding
Study Start Date
April 1, 2002 (Actual)
Primary Completion Date
March 1, 2005 (Actual)
Study Completion Date
May 1, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Depression, Fatigue, Quality of Life
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
methylphenidate hydrochloride
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward G. Shaw, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Western Regional, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2726
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-9479
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1030
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43206
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States

12. IPD Sharing Statement

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

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