Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors

Completed · Phase 3 · Has a placebo group

Conditions studied: Brain Tumors, Metastatic Disease

In brief

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.

Key facts

Study ID

NCT00369785

Run by

Wake Forest University Health Sciences

People needed

198

Starts

2008-02-01

Expected to finish

2012-07-01

Last updated by the study team

2021-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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