Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Cognitive/Functional Effects Fatigue Metastatic Cancer Psychosocial Effects of Cancer and Its Treatment Radiation Toxicity |
Drug: donepezil hydrochloride Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Phase III Double Blind, Placebo Controlled Study of Donepezil in the Irradiated Brain |
- Fatigue, subjective confusion, and cognitive performance at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Mood at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Quality of life at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 198 |
| Study Start Date: | January 2008 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral donepezil hydrochloride once or twice daily for up to 24 weeks in the absence of unacceptable toxicity.
|
Drug: donepezil hydrochloride
Given orally
|
|
Placebo Comparator: Arm II
Patients receive oral placebo once or twice daily for up to 24 weeks in the absence of unacceptable toxicity.
|
Other: placebo
Given orally
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Diagnosis of primary or metastatic brain tumor
Completed a course of ≥ 30 Gy fractionated whole-brain irradiation or large-field partial-brain irradiation for primary or metastatic brain tumor ≥ 6 months prior to study entry
Meets the following criteria:
- Single-fraction stereotactic radiosurgery as a boost after external-beam radiotherapy
- No polifeprosan 20 with carmustine implant (Gliadel wafers), GliaSite®, or other type of brain brachytherapy
- No convection-enhanced delivery of immunotoxins
- No other investigational modalities as adjuvant therapy after external-beam radiotherapy
- Must have treatment records (total dose, dose per fraction, and isodose curves) available for all prior radiotherapy (external-beam radiotherapy, brachytherapy, and/or stereotactic radiosurgery)
- Patients receiving prophylactic cranial irradiation are eligible
- No radiographic evidence of brain disease OR stable brain disease, defined as no evidence of tumor progression within the past 3 months
No brain metastases with progressive extracranial primary or metastatic disease
- Extracranial primary or metastatic disease must be stable or have responded to local and/or systemic treatment within the past 3 months
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 30 weeks
- Karnofsky performance status 60-100%
- Patients must have a phone
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No sick sinus syndrome or supraventricular arrhythmias
- No hypersensitivity to donepezil hydrochloride
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 2 weeks since prior and no other concurrent dementia drugs, cognitive enhancers, neuroleptics, and/or anti-parkinsonian agents
- Concurrent steroids, anti-cholinergics, anti-epileptics, anti-depressants, and/or sedatives/benzodiazepines allowed provided patient is on a stable or decreasing dose
- Concurrent narcotic analgesics allowed provided the patient is on a stable dose and/or prn basis
No other planned therapy, including surgery, brain irradiation of any type, chemotherapy, or immunotherapy, for the next 30 weeks for brain or extracranial primary metastatic disease
- Concurrent trastuzumab (Herceptin®) for breast cancer allowed
- Concurrent hormonal therapy for breast or prostate cancer allowed
- No concurrent bethanechol, ketoconazole, quinidine, or succinylcholine
No prior GliaSite or other type of brain brachytherapy, convection enhanced delivery of immunotoxins, and/or any other investigational modalities for treatment of brain tumor
- Gliadel wafers allowed
- No concurrent chemotherapy
Contacts and Locations| United States, Kansas | |
| Associates in Womens Health, PA - North Review | |
| Wichita, Kansas, United States, 67208 | |
| Cancer Center of Kansas, PA - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | |
| Wichita, Kansas, United States, 67208 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Maine | |
| Central Maine Comprehensive Cancer Center at Central Maine Medical Center | |
| Lewiston, Maine, United States, 04240 | |
| United States, New Hampshire | |
| New Hampshire Oncology - Hematology, PA - Hooksett | |
| Hooksett, New Hampshire, United States, 03106 | |
| Lakes Region General Hospital | |
| Laconia, New Hampshire, United States, 03246 | |
| United States, New York | |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| United States, North Dakota | |
| CCOP - MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| Trinity CancerCare Center | |
| Minot, North Dakota, United States, 58701 | |
| United States, Ohio | |
| Summa Center for Cancer Care at Akron City Hospital | |
| Akron, Ohio, United States, 44309-2090 | |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| United States Air Force Medical Center - Wright-Patterson | |
| Wright-Patterson Afb, Ohio, United States, 45433-5529 | |
| United States, Tennessee | |
| Thompson Cancer Survival Center | |
| Knoxville, Tennessee, United States, 37916 | |
| United States, Wisconsin | |
| Gundersen Lutheran Center for Cancer and Blood | |
| La Crosse, Wisconsin, United States, 54601 | |
| Principal Investigator: | Stephen Rapp, PhD | Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Edward G. Shaw, Wake Forest University Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00369785 History of Changes |
| Other Study ID Numbers: | CCCWFU91105, CCCWFU-91105 |
| Study First Received: | August 24, 2006 |
| Last Updated: | June 28, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Wake Forest University:
|
cognitive/functional effects fatigue psychosocial effects of cancer and its treatment radiation toxicity tumors metastatic to brain adult brain stem glioma adult central nervous system germ cell tumor adult choroid plexus tumor adult craniopharyngioma adult mixed glioma adult anaplastic meningioma meningeal melanocytoma adult meningeal hemangiopericytoma adult grade I meningioma adult grade II meningioma |
adult grade III meningioma adult papillary meningioma adult anaplastic oligodendroglioma adult oligodendroglioma adult pineoblastoma adult pineocytoma adult anaplastic astrocytoma adult diffuse astrocytoma adult glioblastoma adult giant cell glioblastoma adult gliosarcoma adult pilocytic astrocytoma adult ependymoblastoma adult medulloblastoma adult supratentorial primitive neuroectodermal tumor (PNET) |
Additional relevant MeSH terms:
|
Fatigue Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Nervous System Neoplasms Central Nervous System Neoplasms Radiation Injuries Signs and Symptoms Neoplastic Processes Pathologic Processes Neoplasms by Site Nervous System Diseases |
Wounds and Injuries Donepezil Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013