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Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors | Clinical Trials | Clareo Health

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

Phase III Double Blind, Placebo Controlled Study of Donepezil in the Irradiated Brain

NCT00369785•Wake Forest University Health Sciences

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
+8 more criteria