Ignite Creation Date:
2024-05-06 @ 10:44 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03342443
Status:
RECRUITING
Last Update Posted:
2019-04-12
First Post:
2017-05-05
Brief Title:
Effect of Memantine on 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:
Effect of Memantine on Radiotherapy-related Cognitive Impairment
Status:
RECRUITING
Status Verified Date:
2019-04
Last Known Status:
None
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 thalidomide 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 memantine
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 memantine
Detailed Description:
Application of radiotherapy to patients with head and neck cancer isa mainstay treatment in contemporaryoncology practice However patients who received radiation are vulnerable to development of cognitive impairmentThere is no acknowledged and effective standard treatment for radiotherapy-related cognitive impairment We supposed that memantine as the N-methyl-D-aspartate receptor antagonist 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 memantineon cognition in radiotherapy-related cognitive impairment
Secondary objectives
To evaluate the effect of memantine 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 memantine or placebo Memantine will be supplied as 10 mg per pill to be taken by mouth Placebo will be supplied as substitute of 10 mg memantine 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 memantine with a dosage of 5 microgram at 8 am daily for one week Week 1 then 5 microgram at 8 am and5 microgram at 5 pm for one week Week 2 then 10 microgram at 8 am and 5 microgram at 5 pm for one week Week 3 then 10 microgram at 8 am and 10 microgram at 5 pm for 21 weeks Week 4-24 in the absence of unacceptable toxicity or severe deterioration
Arm ІI Patients receive placebo with a dosage of one half pill at 8 am daily for one week Week 1 then one half pill at 8 am and one half pill at 5 pm for one week Week 2 then one pill at 8 am and one half pill at 5 pm for one week Week 3 then one pill at 8 am and one pill at 5 pm for 21 weeks Week 4-24 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 memantineon cognition in radiotherapy-related cognitive impairment
Secondary objectives
To evaluate the effect of memantine 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 memantine or placebo Memantine will be supplied as 10 mg per pill to be taken by mouth Placebo will be supplied as substitute of 10 mg memantine 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 memantine with a dosage of 5 microgram at 8 am daily for one week Week 1 then 5 microgram at 8 am and5 microgram at 5 pm for one week Week 2 then 10 microgram at 8 am and 5 microgram at 5 pm for one week Week 3 then 10 microgram at 8 am and 10 microgram at 5 pm for 21 weeks Week 4-24 in the absence of unacceptable toxicity or severe deterioration
Arm ІI Patients receive placebo with a dosage of one half pill at 8 am daily for one week Week 1 then one half pill at 8 am and one half pill at 5 pm for one week Week 2 then one pill at 8 am and one half pill at 5 pm for one week Week 3 then one pill at 8 am and one pill at 5 pm for 21 weeks Week 4-24 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