Clinical trial NCT00369785
Conditions: Brain Tumors Metastatic Disease
Keywords: 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) adult anaplastic ependymoma adult ependymoma adult myxopapillary ependymoma adult subependymoma
Sponsor: Wake Forest University Health Sciences
Start date: 2008-02-01; Completion date: 2012-07-01
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

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.

Arms: arm 1: Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day arm 2: Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day
Interventions: intervention 1: donepezil hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily intervention 2: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day

Protocol documents: