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
3 other identifiers
interventional
198
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2008
Typical duration for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2006
CompletedFirst Posted
Study publicly available on registry
August 29, 2006
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
March 9, 2017
CompletedOctober 20, 2021
September 1, 2021
4.4 years
August 24, 2006
July 15, 2015
September 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Memory as Quantified by HVLT-immediate Recall
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.
24 weeks
Memory as Quantified by the HVLT-discrimination
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.
24 weeks
Study Arms (2)
Arm I - Donepezil
EXPERIMENTALWeeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day
Arm II - Control
PLACEBO COMPARATORWeeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day
Interventions
Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily
Eligibility Criteria
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.
- +3 more criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
Lewiston, Maine, 04240, United States
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, 03106, United States
Lakes Region General Hospital
Laconia, New Hampshire, 03246, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, 11030, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122, United States
Trinity CancerCare Center
Minot, North Dakota, 58701, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Air Force Base, Ohio, 45433-5529, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, 54601, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Doug Case
- Organization
- Wake Forest NCORP Research Base
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Rapp, PhD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2006
First Posted
August 29, 2006
Study Start
February 1, 2008
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
October 20, 2021
Results First Posted
March 9, 2017
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share