Determining the effect of memantine on neurological disorders in patients with brain tumors undergoing radiotherapy
Design
In this phase 3 study, a double-blind randomized clinical trial of 70 radiotherapy candidate patients was randomly divided into two groups of 35: memantine and placebo.
Settings and conduct
This study was performed in 2022 in Seyed Al-Shohada Hospital in Isfahan. In this study, patients and the person evaluating the outcome of treatment are unaware of the type of medication received by patients.
Participants/Inclusion and exclusion criteria
In this study, patients with brain tumors who have undergone radiotherapy and have no history of neurological disorders are included in the study.
Intervention groups
70 patients with brain tumors and candidate for radiotherapy are divided into two groups of 35. In the first group, two 5 mg Memantine tablets are given daily 12 hours after a meal and in the control group, placebo tablets are prescribed at the same dose and time. Drug and placebo use in all patients lasts up to 6 weeks
Main outcome variables
Cognitive impairment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211029052903N1
Registration date:2023-01-17, 1401/10/27
Registration timing:registered_while_recruiting
Last update:2023-01-17, 1401/10/27
Update count:0
Registration date
2023-01-17, 1401/10/27
Registrant information
Name
Susan Andalibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3233 7964
Email address
susan.andalibi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Memantine on cognitive impairment in patients with brain tumor under radiotherapy
Public title
Evaluation of the effect of Memantine in patients with brain tumors
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with a brain tumor
Candidate for radiotherapy
Satisfaction to participate in the study
Exclusion criteria:
Drug allergy to memantine
History of neurological disorders
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients in two groups is done by simple random method. In this method, the letter I is written on 35 cards and the letter C is written on 35 sheets. All cards are placed in a box and mixed well. When each person enters the study, a card is taken out of the box. According to the letter recorded on the sheet, the patient is assigned to one of the two groups I (intervention) and C (control).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the outcome assessor are unaware of the type of medication they are receiving. The medicine and placebo are prepared in similar and coded packages and are given to the patients by the research doctor, but the person who evaluates the outcome of the treatment is unaware of the type of medicine received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Khoram street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
IR.MUI.MED.REC.1397.320
Health conditions studied
1
Description of health condition studied
Cognitive Impairment
ICD-10 code
G31.84
ICD-10 code description
Mild cognitive impairment, so stated
Primary outcomes
1
Description
Cognitive Impariment
Timepoint
Before and 6 weeks after the start of the intervention
Method of measurement
Mini-Mental State Exam(MMSE)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Daily intake of two 5 mg memantine tablets 12 hours after a meal for 6 weeks
Category
Treatment - Drugs
2
Description
Control group: Receiver of a placebo pill similar to Memantine at the same dose and time as the intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyedoshohada hospital
Full name of responsible person
Susan Andalibi
Street address
Khoram street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
susan.andalibi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3792 3060
Email
m_siavash@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Simin Hemati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Khoram street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
s_hemati@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Emami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Khoram street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
0098 36692174
Email
h_emami@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
statistical Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
0098 36692174
Email
al.mehrabi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The plan belongs to a government agency and cannot be shared