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Assessment of the effect of memantine in the treatment of chemotherapy-induced peripheral neuropathy: double-blind randomized clinical trial

Protocol summary

Study aim
Evaluation of the effects of memantine on the symptoms of peripheral neuropathy induced by chemotherapy drugs
Design
The study, which will be performed as a double-blind clinical trial, 180 patients with cancer candidate chemotherapy will be divided into two experimental (n = 90) and placebo (n = 90) groups based on a random number table. The experimental group will receive memantine and the second will receive placebo.
Settings and conduct
After randomly assigning individuals to groups, their neuropathy will be assessed. Demographic information, type of cancer & treatment, duration of chemotherapy, etc. will be recorded. The drug is started at a dose of 5 ml and continued with 20 ml. The duration of medication for both groups will be 8 weeks. Finally, participants' neuropathy will be examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People with any malignancy seek chemotherapy with grade 2 neuropathy or higher. Exclusion criteria: Patients with hypertension, acute heart failure, diabetes (types 1 and 2), peripheral vascular patients, amantadine, ketamine, L-dopa, anticholinergic agonists, barbiturates, neuroleptics, IMAO, antispasmodics Baclofen, phenytoin, hydrochlorothiazide and warfarin
Intervention groups
The first group as the experimental group includes patients receiving memantine. The second group will be considered as the placebo group, which will include patients receiving placebo.
Main outcome variables
Chemotherapy induced peripheral neuropathic pain severity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160310026998N12
Registration date: 2020-08-19, 1399/05/29
Registration timing: prospective

Last update: 2020-08-19, 1399/05/29
Update count: 0
Registration date
2020-08-19, 1399/05/29
Registrant information
Name
Saba Ghaffary
Name of organization / entity
Faculty of Pharmacy, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33266042
Email address
ghaffarys@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of memantine in the treatment of chemotherapy-induced peripheral neuropathy: double-blind randomized clinical trial
Public title
Assessment the effect of memantine in the treatment of chemotherapy-induced peripheral neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with any malignancy who have had grade 2 or higher neuropathy following chemotherapy
Exclusion criteria:
Patients with hypertension Acute heart failure type 1 & 2 diabetes mellitus peripheral vascular disease 285/5000Patients taking drugs (amantadine, ketamine, dextromethorphan, L-dopa; dopaminergic, anticholinergic agonists, barbiturates, neuroleptics, IMAO, antispasmodics, dantrolene or baclofen, phenytoinquinotine, cimetidine, ranitidine And warfarin) alcohl use People of reproductive ages, pregnancy and lactation People taking other neuropathic medications such as gabapentin, pregabalin and dologestin Patients with brain or leptomeningeal metastasis
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
180 patients with cancer who are candidates for chemotherapy treatment and referred to the clinic or hospital ward of Shahid Ghazi Hospital will be screened and will select by including & excluding criteria. Patients will then be divided into two groups through simple randomization procedure based on a table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients with a variety of cancers, who will be candidates for the study based on the including & excluding criteria , will enter the study after completing informed consent, but will not be aware of the main drug or placebo. Also, physicians assisting the researcher who prescribe the drug, will not inform the type of main drug or placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee at Tabriz University of Medical Sciences
Street address
Shahid Ghazi hospital, Tabriz University of Medical Sciences, Daneshgah street
City
tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2020-06-06, 1399/03/17
Ethics committee reference number
IR.TBZMED.REC.1399.211

Health conditions studied

1

Description of health condition studied
chemotherapy-induced peripheral neuropathy in patients with cancer
ICD-10 code
G90.0
ICD-10 code description
Idiopathic peripheral autonomic neuropathy

Primary outcomes

1

Description
severity of neuropathic symptoms
Timepoint
At PRE intervention (baseline phase) & 8 weeks after intervention
Method of measurement
McGill pain questionnaire, Neuropathic Pain, Neuropathic Pain Symptom Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients undergoing chemotherapy with symptoms of peripheral neuropathy first receive memantine at a dose of 5 mg for three days, and every three days 5 mg is added to the previous dose, and finally at a dose of 20 mg, treatment will continue for eight weeks.
Category
Treatment - Drugs

2

Description
Control group: Patients undergoing chemotherapy with symptoms of peripheral neuropathy as a placebo group will receive placebo for 8 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Ghazi Hospital in Tabriz, Iran
Full name of responsible person
Saba Ghaffary
Street address
Shahid Ghazi hospital, Tabriz University of Medical Sciences, Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3336 5010
Email
ghaffarys@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saba Ghaffry
Street address
Central building of Tabriz University of Medical Sciences, Golgasht boulevard, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
51665158
Phone
+98 41 3336 5010
Email
ghaffarys@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
saba Ghaffary
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Ghazi hospital, Tabriz University of Medical Sciences, Daneshgah street
City
tabriz
Province
East Azarbaijan
Postal code
14766 - 51664
Phone
+41 33365010
Email
ghaffarys@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saba Ghaffry
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Ghazi hospital,Tabriz University of Medical Sciences, Daneshgah street
City
tabriz
Province
East Azarbaijan
Postal code
14766 - 51664
Phone
+41 33365010
Email
ghaffarys@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saba Ghaffary
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Ghazi hospital, Tabriz University of Medical Sciences, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
14766 - 51664
Phone
+41 33365010
Email
ghaffarys@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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