Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors
NCT ID: NCT00369785
Last Updated: 2021-10-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
198 participants
INTERVENTIONAL
2008-02-29
2012-07-01
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Arm I - Donepezil
Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day
donepezil hydrochloride
Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily
Arm II - Control
Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day
Placebo
Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day
Interventions
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donepezil hydrochloride
Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily
Placebo
Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Stephen Rapp, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
Lewiston, Maine, United States
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, United States
Lakes Region General Hospital
Laconia, New Hampshire, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, United States
Trinity CancerCare Center
Minot, North Dakota, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Air Force Base, Ohio, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States
Countries
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Related Links
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Data Available: Select individual patient-level data form this trial can be requested from the NCTN/NCORP Data Archive
Other Identifiers
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REBACCCWFU 91105
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00000551
Identifier Type: -
Identifier Source: org_study_id