NCT00369785 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2021-10-20

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Memory as Quantified by HVLT-immediate Recall

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outcome · POSTED

Memory as Quantified by the HVLT-discrimination

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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. * 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. EXCLUSION CRITERIA: * 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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day
intervention Names
Drug: donepezil hydrochloride
label
Arm I - Donepezil
type
EXPERIMENTAL
description
Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day
intervention Names
Drug: Placebo
label
Arm II - Control
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
Arm I - Donepezil
description
Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily
name
donepezil hydrochloride
other Names
Donepezil
type
DRUG
arm Group Labels
Arm II - Control
description
Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day
name
Placebo
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: QUADRUPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 198
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Memory is quantified using the Hopkins Verbal Learning Test (HVLT) - immediate recall. Participants are asked to recall 12 words. Each recalled word is given one point. They are given three trials. The total score is the sum of the recalled words. The range for HVLT-Immediate recall is 0 to 36. Higher scores represent better memory.
measure
Memory as Quantified by HVLT-immediate Recall
time Frame
24 weeks
description
In the Hopkins Verbal Learning Test - discrimination, participants are given lists of 12 correct words and 12 incorrect words. HVLT-discrimination is the number of correctly recognized words minus the number incorrectly recognized. The range for this outcome measure is -12 to 12. Higher scores represent better memory.
measure
Memory as Quantified by the HVLT-discrimination
time Frame
24 weeks

Full study description

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.

Source references