AzTrials
AzTrials

Brain and Central Nervous System TumorsPhase 3NCT00031798

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

A Phase 3 study testing methylphenidate hydrochloride, quality-of-life assessment and radiation therapy in people with Brain and Central Nervous System Tumors and Cognitive/Functional Effects, run by Wake Forest University Health Sciences at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
methylphenidate hydrochloride, quality-of-life assessment and radiation therapy
Type of treatment
Surgery or procedure
How many people
Not given
Where
7 sitesUnited States
Study dates
1 Apr 2002to 1 May 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • CCOP - Southeast Cancer Control Consortium

    Goldsboro, North Carolina, 27534-9479

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006-2726

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1030

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
methylphenidate hydrochloride, quality-of-life assessment, radiation therapy
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
Medical subject headings
Central Nervous System Neoplasms, Depression, Fatigue, Brain Neoplasms, Glioblastoma, Astrocytoma, Oligodendroglioma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • methylphenidate hydrochlorideDrug

  • quality-of-life assessmentProcedure or surgery

  • radiation therapyRadiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study start1 Apr 2002
  3. Primary completion1 Mar 2005
  4. Study completion1 May 2006

Why it stopped: low accrual; loss of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00031798
Sponsor's protocol ID
REBACDR0000069227
Other IDs
CCCWFU-97600, NCI-P02-0211
Status last verified
Sep 2021
First submitted
8 Mar 2002
Last updated
9 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing methylphenidate hydrochloride, quality-of-life assessment and radiation therapy in people with Brain and Central Nervous System Tumors and Cognitive/Functional Effects, run by Wake Forest University Health Sciences at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: low accrual; loss of funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00031798.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in