Trial record 1 of 1 for:    CCCWFU 91105
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Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00369785
First received: August 24, 2006
Last updated: June 28, 2012
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Cognitive/Functional Effects
Fatigue
Metastatic Cancer
Psychosocial Effects of Cancer and Its Treatment
Radiation Toxicity
Drug: donepezil hydrochloride
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Phase III Double Blind, Placebo Controlled Study of Donepezil in the Irradiated Brain

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Fatigue, subjective confusion, and cognitive performance at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mood at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Quality of life at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 198
Study Start Date: January 2008
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral donepezil hydrochloride once or twice daily for up to 24 weeks in the absence of unacceptable toxicity.
Drug: donepezil hydrochloride
Given orally
Placebo Comparator: Arm II
Patients receive oral placebo once or twice daily for up to 24 weeks in the absence of unacceptable toxicity.
Other: placebo
Given orally

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of primary or metastatic brain tumor
  • Completed a course of ≥ 30 Gy fractionated whole-brain irradiation or large-field partial-brain irradiation for primary or metastatic brain tumor ≥ 6 months prior to study entry

    • Meets the following criteria:

      • Single-fraction stereotactic radiosurgery as a boost after external-beam radiotherapy
      • No polifeprosan 20 with carmustine implant (Gliadel wafers), GliaSite®, or other type of brain brachytherapy
      • No convection-enhanced delivery of immunotoxins
      • No other investigational modalities as adjuvant therapy after external-beam radiotherapy
  • Must have treatment records (total dose, dose per fraction, and isodose curves) available for all prior radiotherapy (external-beam radiotherapy, brachytherapy, and/or stereotactic radiosurgery)
  • Patients receiving prophylactic cranial irradiation are eligible
  • No radiographic evidence of brain disease OR stable brain disease, defined as no evidence of tumor progression within the past 3 months
  • No brain metastases with progressive extracranial primary or metastatic disease

    • Extracranial primary or metastatic disease must be stable or have responded to local and/or systemic treatment within the past 3 months

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 30 weeks
  • Karnofsky performance status 60-100%
  • Patients must have a phone
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No sick sinus syndrome or supraventricular arrhythmias
  • No hypersensitivity to donepezil hydrochloride

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 2 weeks since prior and no other concurrent dementia drugs, cognitive enhancers, neuroleptics, and/or anti-parkinsonian agents
  • Concurrent steroids, anti-cholinergics, anti-epileptics, anti-depressants, and/or sedatives/benzodiazepines allowed provided patient is on a stable or decreasing dose
  • Concurrent narcotic analgesics allowed provided the patient is on a stable dose and/or prn basis
  • No other planned therapy, including surgery, brain irradiation of any type, chemotherapy, or immunotherapy, for the next 30 weeks for brain or extracranial primary metastatic disease

    • Concurrent trastuzumab (Herceptin®) for breast cancer allowed
    • Concurrent hormonal therapy for breast or prostate cancer allowed
  • No concurrent bethanechol, ketoconazole, quinidine, or succinylcholine
  • No prior GliaSite or other type of brain brachytherapy, convection enhanced delivery of immunotoxins, and/or any other investigational modalities for treatment of brain tumor

    • Gliadel wafers allowed
  • No concurrent chemotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00369785

Locations
United States, Kansas
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Maine
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
Lewiston, Maine, United States, 04240
United States, New Hampshire
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, United States, 03106
Lakes Region General Hospital
Laconia, New Hampshire, United States, 03246
United States, New York
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States, 11030
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
Trinity CancerCare Center
Minot, North Dakota, United States, 58701
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Afb, Ohio, United States, 45433-5529
United States, Tennessee
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
United States, Wisconsin
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Stephen Rapp, PhD Wake Forest School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Edward G. Shaw, Wake Forest University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00369785     History of Changes
Other Study ID Numbers: CCCWFU91105, CCCWFU-91105
Study First Received: August 24, 2006
Last Updated: June 28, 2012
Health Authority: United States: Federal Government

Keywords provided by Wake Forest School of Medicine:
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)

Additional relevant MeSH terms:
Fatigue
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Nervous System Neoplasms
Central Nervous System Neoplasms
Radiation Injuries
Signs and Symptoms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Nervous System Diseases
Wounds and Injuries
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014