Clinical trial NCT00031798: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: CCOP - Western Regional, Arizona
state: Arizona
city: Decatur
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: New Orleans
country: United States
facility: MBCCOP - LSU Health Sciences Center
state: Louisiana
city: Goldsboro
country: United States
facility: CCOP - Southeast Cancer Control Consortium
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Columbus
country: United States
facility: CCOP - Columbus
state: Ohio
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Edward G. Shaw, MD
role: STUDY_CHAIR
References: