Since taxane drugs have many side effects for chemotherapy and their most important complication is neuropathic pain and cannot be controlled and treated with its prescribed drug, gabapentin, this project is very important and it is hoped that curcumin supplementation will have a significant effect on control and treatment. Have neuropathic pains caused by taking taxanes.
Design
Drugs will be coded by a third party (outside the study). Then the drug label will be removed and the numbered drugs will be provided to the student. The student only sees the number and does not know the type of medicine. The patient only knows that he is participating in a study that will help his treatment process and is completely unaware of the prescription of the type of medicine to be taken. After prescribing the drugs and recording the data by the student, the information is provided to the statistical analyst. After the statistical analysis, the data will be provided to the researcher responsible for writing the article. In order to write the article, the main researcher will match the number of drugs with the type by referring to the third person.
Settings and conduct
Kerman Javadalameh Clinic
Participants/Inclusion and exclusion criteria
Inclusion: All cancer patients who show symptoms of neuropathy caused by taxane chemotherapy drugs and are confirmed by NCV test.
Non-entry: Cancer patients who have neuropathy caused by factors other than chemotherapy drugs, such as diabetics, pregnant and lactating mothers, people who receive painkillers, such as morphine
Intervention groups
1- Treatment group receiving curcumin capsules 2- Control group receiving placebo 3- Positive control group receiving gabapentin
Main outcome variables
Severity of neuropathy (based on questionnaire items) of patients receiving taxane drugs
General information
Reason for update
Acronym
کورکومین و نوروپاتی داروی شیمی درمانی
IRCT registration information
IRCT registration number:IRCT20220802055602N1
Registration date:2022-08-20, 1401/05/29
Registration timing:registered_while_recruiting
Last update:2022-08-20, 1401/05/29
Update count:0
Registration date
2022-08-20, 1401/05/29
Registrant information
Name
naeem nikpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 8000
Email address
fatemeh.dsdt4@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-11, 1401/05/20
Expected recruitment end date
2022-10-12, 1401/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin supplementation on pain caused by neuropathy in patients treated with taxanes
Public title
The effect of curcumin supplementation on pain caused by neuropathy in patients treated with taxanes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having symptoms of neuropathy
Confirmation of neuropathy by ncv test and doctor's examination
Exclusion criteria:
Cancer patients who have neuropathy caused by factors other than chemotherapy drugs, such as diabetics, pregnant and lactating mothers, people who receive painkillers such as morphine
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, individual randomization is random allocation to intervention and control groups through a table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs will be coded by a third party (external to the study) (eg, main treatment group #1, placebo #2, and positive control #3). Then the drug label will be removed and the numbered drugs will be given to the student (responsible for following up and correct prescription of drugs). The student only sees the number and does not know the type of medicine. The patient only knows that he is participating in a study that will help his treatment process and is completely unaware of the prescription of the type of medicine to be taken. After prescribing the drugs and recording the data by the student, the information is provided to the statistical analyst (who also only knows the number and does not know the type of drug). After the statistical analysis, the data will be provided to the researcher responsible for writing the article. In order to write the article, the main researcher will match the number of drugs with their type by referring to a third party (outside the study).
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Kerman University of Medical Sciences
Street address
haft bagh alavi
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2022-06-05, 1401/03/15
Ethics committee reference number
IR.KMU.REC.1401.150
Health conditions studied
1
Description of health condition studied
Neuropathy caused by receiving taxanes
ICD-10 code
ICD-10 code description
2
Description of health condition studied
cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
شدت نوروپاتی (بر اساس آیتم های پرسشنامه) بیمارانی که داروی شیمی درمانی دسته تاکسان ها دریافت میکنند
Timepoint
Evaluation of neuropathy in patients is before the administration of drugs, in the middle of the administration period (45 days after the administration of the interventions i.e. the administration of the first dose of drugs, placebo and positive control) and after the treatment (up to 1 month after the last administration of the interventions).
Method of measurement
Nerve conduction speed test, doctor's examination and questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients with chemotherapy-induced neuropathy who receive 500 mg curcumin tablets once a day for up to 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Javadalameh Clinic
Full name of responsible person
naeem nikpour
Street address
abozar 25
City
kerman
Province
Kerman
Postal code
7617763811
Phone
+98 34 3251 2098
Email
kmuamar@kmu.ac.i
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza malekpour afshar
Street address
ebne sina
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Email
kmuamar@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Rezaie
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
HAFT BAGH ALAVI
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5690
Email
Fatemeh.dsdt4@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Rezaie
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
haft baghe alavi
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5690
Email
Fatemeh.dsdt4@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Rezaie
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
haft bagh alavi
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5690
Email
fatemeh.dsdt4@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
Failure to make a decision
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document