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| Sponsor: | Wake Forest University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00369785 |
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 III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | Phase III Double Blind, Placebo Controlled Study of Donepezil in the Irradiated Brain |
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | June 2010 (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
|
OBJECTIVES:
Primary
Secondary
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.
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:
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:
No brain metastases with progressive extracranial primary or metastatic disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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
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
Contacts and Locations| United States, Kansas | |
| Associates in Womens Health, PA - North Review | Recruiting |
| Wichita, Kansas, United States, 67208 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Wichita | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | Recruiting |
| Wichita, Kansas, United States, 67208 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Wesley Medical Center | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| CCOP - Wichita | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| United States, New Hampshire | |
| New Hampshire Oncology - Hematology, PA - Hooksett | Recruiting |
| Hooksett, New Hampshire, United States, 03106 | |
| Contact: Frederick M. Briccetti, MD 603-224-2556 | |
| Lakes Region General Hospital | Recruiting |
| Laconia, New Hampshire, United States, 03246 | |
| Contact: Charles H. Catcher, MD 603-224-2556 | |
| United States, New York | |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | Recruiting |
| Manhasset, New York, United States, 11030 | |
| Contact: Clinical Trials Office - Don Monti Comprehensive Cancer Center 516-734-8900 | |
| United States, North Dakota | |
| CCOP - MeritCare Hospital | Recruiting |
| Fargo, North Dakota, United States, 58122 | |
| Contact: Preston D. Steen, MD 701-234-2397 | |
| United States, Ohio | |
| Summa Center for Cancer Care at Akron City Hospital | Recruiting |
| Akron, Ohio, United States, 44309-2090 | |
| Contact: Clinical Trials Office - Akron City Hospital 330-375-6101 | |
| United States Air Force Medical Center - Wright-Patterson | Recruiting |
| Wright-Patterson Afb, Ohio, United States, 45433-5529 | |
| Contact: E. Ronald Hale 937-257-9133 | |
| United States, Tennessee | |
| Thompson Cancer Survival Center | Recruiting |
| Knoxville, Tennessee, United States, 37916 | |
| Contact: Clinical Trials Office - Thompson Cancer Survival Center 865-541-1812 | |
| United States, Wisconsin | |
| Gundersen Lutheran Center for Cancer and Blood | Recruiting |
| La Crosse, Wisconsin, United States, 54601 | |
| Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center 608-775-2385 cancerctr@gundluth.org | |
| Principal Investigator: | Stephen Rapp, PhD | Wake Forest University |
More Information
| Responsible Party: | Edward G. Shaw, Wake Forest University Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00369785 History of Changes |
| Other Study ID Numbers: | CDR0000485228, CCCWFU-91105 |
| Study First Received: | August 24, 2006 |
| Last Updated: | April 7, 2011 |
| Health Authority: | Unspecified |
|
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) |
|
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 |