UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical effectiveness of Donepezil Hydrochloride for radiation-induced memory disturbance in patients with brain tumor
Title of the study (Brief title)	Clinical effectiveness of Donepezil Hydrochloride for radiation-induced memory disturbance in patients with brain tumor
Region	Japan

Condition
Condition	brain tumor
Classification by specialty	Radiology Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate clinical effectiveness of Donepezil Hydrochloride to radiation-induced memory disturbance in patients with brain tumor
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Improvement of memory disturbance
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Donepezil Hydrochloride
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. no history of radiation therapy to brain 2. expect more than 6 months survival 3. patiets with small cell lung cancer who will receive prophylactic cranial irradiation 4.patiets with multiple brain tumors, without midline shift, nor without huge tumors of more than 5cm diameter 5.patients without disease of contra-indication to Donepezil Hydrochloride
Key exclusion criteria	Patients of contra-indication to Donepezil Hydrochloride
Target sample size	30

Research contact person
Name of lead principal investigator	Ryohei Sasaki
Organization	Kobe University Hospital
Division name	Division of Radiation Oncology
Address	7-5-2 Kusunokicho Chuouku Kobe city
TEL	078-382-6104
Email	rsasaki@med.kobe-u.ac.jp

Public contact
Name of contact person	Yasuo Ejima
Organization	Kobe University Hospital
Division name	Division of Radiation Oncology
Address	7-5-2 Kusunokicho Chuouku Kobe city
TEL	078-382-6104
Homepage URL
Email	ejimay@med.kobe-u.ac.jp

Sponsor
Institute	Department od Radiology, Kobe University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department od Radiology, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2009 Year 06 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2009 Year 05 Month 31 Day
Anticipated trial start date	2009 Year 06 Month 01 Day
Last follow-up date	2017 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 05 Month 07 Day
Last modified on	2016 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002367