Ignite Creation Date:
2024-05-06 @ 12:59 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03907371
Status:
UNKNOWN
Last Update Posted:
2019-11-25
First Post:
2019-03-27
Brief Title:
The Effect of Donepezil in Radiotherapy-related Cognitive Impairment
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
The Effect of Donepezil in Radiotherapy-related Cognitive Impairment a Randomized Double-blind Placebo-controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose This randomized double-blind placebo-controlled clinical trial aims to evaluate the therapeutic effects of donepezil in radiotherapy-related cognitive impairment
Further study details as provided by Sun Yat-sen Memorial Hospital Sun Yat-sen University Yameitang
Primary outcome measure cognitive improvement which is determined by the difference value of ADAS-cog score before and after the treatment of donepezil
Further study details as provided by Sun Yat-sen Memorial Hospital Sun Yat-sen University Yameitang
Primary outcome measure cognitive improvement which is determined by the difference value of ADAS-cog score before and after the treatment of donepezil
Detailed Description:
Application of radiotherapy to patients with head and neck cancer is a mainstay treatment in contemporary oncology practice However patients who received radiation are vulnerable to development of cognitive impairment There is no acknowledged and effective standard treatment for radiotherapy-related cognitive impairment The investigators supposed that donepezil as a cholinesterase inhibitor would relieve radiotherapy-related cognitive impairment after head and neck cancer and would improve the life quality for these patients and their families
Primary objectives This randomized double-blind placebo-controlled clinical trial aims to evaluate the efficacy of donepezil on cognition in radiotherapy-related cognitive impairment
Secondary objectives
To evaluate the effect of donepezil on sleep disorder mood disorder activities of daily living and safety in patients with radiotherapy-related cognitive impairment
OUTLINE This is randomized double-blind placebo-controlled clinical trial Patients will be enrolled and administrated with donepezil or placebo Donepezil will be supplied as 10 mg per pill to be taken by mouth Placebo will be supplied as substitute of 10 mg donepezil per pill to be taken by mouth
Patients will be screened consented enrolled and have a washout period for 6 weeks Then these patients will be randomized to two arms
Arm І Patients receive donepezil with a dosage of 5 milligram at 8 am for one week Week 1 then 10 milligram at 8 am for 23 weeks Week 2-24 in the absence of unacceptable toxicity or severe deterioration
Arm ІI Patients receive placebo with a dosage of one half pill at 8 am for one week Week 1 then one pill at 8 am for 23 weeks Week 2-24 in the absence of unacceptable toxicity or severe deterioration
Primary objectives This randomized double-blind placebo-controlled clinical trial aims to evaluate the efficacy of donepezil on cognition in radiotherapy-related cognitive impairment
Secondary objectives
To evaluate the effect of donepezil on sleep disorder mood disorder activities of daily living and safety in patients with radiotherapy-related cognitive impairment
OUTLINE This is randomized double-blind placebo-controlled clinical trial Patients will be enrolled and administrated with donepezil or placebo Donepezil will be supplied as 10 mg per pill to be taken by mouth Placebo will be supplied as substitute of 10 mg donepezil per pill to be taken by mouth
Patients will be screened consented enrolled and have a washout period for 6 weeks Then these patients will be randomized to two arms
Arm І Patients receive donepezil with a dosage of 5 milligram at 8 am for one week Week 1 then 10 milligram at 8 am for 23 weeks Week 2-24 in the absence of unacceptable toxicity or severe deterioration
Arm ІI Patients receive placebo with a dosage of one half pill at 8 am for one week Week 1 then one pill at 8 am for 23 weeks Week 2-24 in the absence of unacceptable toxicity or severe deterioration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None