- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00369785
Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors
Phase III Double Blind, Placebo Controlled Study of Donepezil in the Irradiated Brain
RATIONALE: Donepezil may help lessen confusion and fatigue and improve mood and quality of life in patients who have undergone radiation therapy for brain tumors. It is not yet known whether donepezil is more effective than a placebo in lessening side effects of radiation therapy in patients with brain tumors.
PURPOSE: This randomized phase III trial is studying donepezil to see how well it works in lessening side effects of radiation therapy compared with a placebo in patients who have undergone radiation therapy for brain tumors.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Compare the effect of donepezil hydrochloride vs placebo, in terms of improving neurocognitive symptom cluster (i.e., cognitive impairment, subjective confusion, and fatigue), in patients who have undergone partial- or whole-brain irradiation for brain tumors.
Secondary
- Compare the effect of these regimens on mood and quality of life in these patients.
OUTLINE: This is a prospective, double-blind, placebo-controlled, randomized, multicenter study. Patients are stratified according to prior brain irradiation type (whole-brain vs partial-brain) and study site. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral donepezil hydrochloride once or twice daily for up to 24 weeks in the absence of unacceptable toxicity.
- Arm II: Patients receive oral placebo once or twice daily for up to 24 weeks in the absence of unacceptable toxicity.
Patients complete self-reported questionnaires (quality of life, fatigue, subjective confusion, neurocognitive battery, and mood) at baseline and 12 and 24 weeks.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Kansas
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Wichita, Kansas, United States, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, United States, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, United States, 67214
- CCOP - Wichita
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Wichita, Kansas, United States, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, United States, 67208
- Associates in Womens Health, PA - North Review
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Maine
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Lewiston, Maine, United States, 04240
- Central Maine Comprehensive Cancer Center at Central Maine Medical Center
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New Hampshire
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Hooksett, New Hampshire, United States, 03106
- New Hampshire Oncology - Hematology, PA - Hooksett
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Laconia, New Hampshire, United States, 03246
- Lakes Region General Hospital
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New York
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Manhasset, New York, United States, 11030
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
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North Dakota
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Fargo, North Dakota, United States, 58122
- CCOP - MeritCare Hospital
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Minot, North Dakota, United States, 58701
- Trinity Cancercare Center
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Ohio
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Akron, Ohio, United States, 44309-2090
- Summa Center for Cancer Care at Akron City Hospital
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Cleveland, Ohio, United States, 44109
- MetroHealth Cancer Care Center at MetroHealth Medical Center
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Wright-Patterson Air Force Base, Ohio, United States, 45433-5529
- United States Air Force Medical Center - Wright-Patterson
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Tennessee
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Knoxville, Tennessee, United States, 37916
- Thompson Cancer Survival Center
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Wisconsin
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La Crosse, Wisconsin, United States, 54601
- Gundersen Lutheran Center for Cancer and Blood
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
- Adults >18 years old.
- Life expectancy of at least > 30 weeks.
- Must have received a prior course of at least 30 Gy fractionated whole or partial brain irradiation for treatment of a primary brain tumor or metastatic disease to the brain.
- Must have completed radiation > 6 months prior to enrollment and have no radiographic evidence of brain disease, or stable brain disease defined as no evidence of tumor progression in the 3 months prior to enrollment.
- Patients who have undergone one or more treatments with single fraction stereotactic radiosurgery (SRS) in addition to whole or partial brain irradiation are eligible, as long as the SRS was completed > 6 months prior to registration if NED or stable disease.
- Radiation treatment records must be available for all prior radiation treatments (external beam and/or SRS).
- Patients who have received PCI (prophylactic cranial irradiation) are eligible.
- Karnofsky Performance Status must be > 60 or ECOG 0-2.
- Treatment with steroids, anti-cholinergics, anti-epileptics, anti-depressants, and /or sedatives/benzodiazepines is acceptable, but the patient must be on a stable or decreasing dose at the time of study entry.
- Patients using narcotic analgesics on a stable dose and/or prn basis are eligible.
- Patients currently on a stable dose of Methylphenidate or Dextramphetamine are eligible.
- For patients with brain metastases, if extracranial primary or metastatic disease is present, it must have responded to local and/or systemic treatment. Must be stable in the 3 months prior to enrollment.
- Must not be receiving chemotherapy at the time of enrollment.
- Patient must not have any planned therapy, including surgery, brain radiation of any type, chemotherapy, or immunotherapy during the next 30 weeks for brain or extracranial primary metastatic disease.
- Hormonal therapy for patients with breast or prostate cancer is acceptable.
- Breast patients receiving therapy with Herceptin are allowed.
- Patients must be able to give informed consent to participate in the study, including signing the consent form.
- Patients must have a telephone.
EXCLUSION CRITERIA:
- Patients cannot be currently taking dementia drugs, cognitive enhancers, neuroleptics, and/or anti-parkinsonian agents. For patients who have used these drugs in the past, they must not have used them in the 2 weeks prior to enrolling on the study.
- Hypersensitivity to donepezil.
- Patients may not currently be taking Ketoconazole or Quindine
- Arrythmias including bradycardia or heartblock
- Patients who have received, GliaSite or other type of brain brachytherapy, (Gliadel Wafers permitted) convection enhanced delivery of immunotoxins, and/or any other investigational modalities for treatment of their brain tumor. The effects of donepezil on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- It is unknown whether donepezil is excreted in breast milk, for this reason women who are currently breast-feeding are not eligible for this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I - Donepezil
Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day
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Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily
Other Names:
|
Placebo Comparator: Arm II - Control
Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day
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Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Memory as Quantified by HVLT-immediate Recall
Time Frame: 24 weeks
|
Memory is quantified using the Hopkins Verbal Learning Test (HVLT) - immediate recall.
Participants are asked to recall 12 words.
Each recalled word is given one point.
They are given three trials.
The total score is the sum of the recalled words.
The range for HVLT-Immediate recall is 0 to 36.
Higher scores represent better memory.
|
24 weeks
|
Memory as Quantified by the HVLT-discrimination
Time Frame: 24 weeks
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In the Hopkins Verbal Learning Test - discrimination, participants are given lists of 12 correct words and 12 incorrect words.
HVLT-discrimination is the number of correctly recognized words minus the number incorrectly recognized.
The range for this outcome measure is -12 to 12. Higher scores represent better memory.
|
24 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stephen Rapp, PhD, Wake Forest University Health Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- fatigue
- adult glioblastoma
- adult giant cell glioblastoma
- adult gliosarcoma
- adult anaplastic astrocytoma
- radiation toxicity
- tumors metastatic to brain
- adult anaplastic ependymoma
- adult anaplastic meningioma
- adult anaplastic oligodendroglioma
- adult brain stem glioma
- adult central nervous system germ cell tumor
- adult choroid plexus tumor
- adult craniopharyngioma
- adult diffuse astrocytoma
- adult ependymoblastoma
- adult ependymoma
- adult medulloblastoma
- adult meningeal hemangiopericytoma
- adult myxopapillary ependymoma
- adult oligodendroglioma
- adult papillary meningioma
- adult pineoblastoma
- adult pineocytoma
- adult subependymoma
- adult supratentorial primitive neuroectodermal tumor (PNET)
- adult grade I meningioma
- adult grade II meningioma
- adult grade III meningioma
- adult mixed glioma
- adult pilocytic astrocytoma
- cognitive/functional effects
- psychosocial effects of cancer and its treatment
- meningeal melanocytoma
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Neoplastic Processes
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Neoplasm Metastasis
- Brain Neoplasms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- IRB00000551
- U10CA081851 (U.S. NIH Grant/Contract)
- REBACCCWFU 91105 (Other Identifier: NCI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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