The radioprotective effect of oral nanocurcumin in thyroid cancer patients after high dose radioactive iodine administration by examining the amount of inflamatory factor TNFα by ELISA test in patients blood serum
1-Reducing the side effects of radioactive iodine radiation in thyroid cancer patients using nanocurcumin radiation protection
Design
Clinical trial with control and intervention group, with parallel groups, single-blind, randomized, phase 3 was conducted on 44 patients.
Settings and conduct
In this experiment, 2 groups will be selected, and blood will be taken from all the people twice during the study, once before the treatment and once after the treatment. Given that we have 2 groups, data randomization: people are categorized and placed in groups completely randomly. The study is a single-blind study and the patients are blind to the study.
Participants/Inclusion and exclusion criteria
the dose received by the patients should be between 150 and 200 mcri and the age of the patients should be between 24 and 79 years. Exclusion criteria: a person has undergone radiotherapy or chemotherapy in the last year, has a certain genetic disease, takes certain drugs, is a smoker, or has been exposed to radiation.
Intervention groups
This study is conducted on patients with differentiated thyroid cancer referred to the nuclear medicine department of Namazi Hospital in Shiraz, whose received dose is 150 to 200 mci. The control group receives a placebo.
Main outcome variables
A blood sample is taken and evaluated once before the radiopharmaceutical and once a week after the treatment.
General information
Reason for update
Acronym
clinical trail
IRCT registration information
IRCT registration number:IRCT20220212054005N1
Registration date:2023-02-18, 1401/11/29
Registration timing:retrospective
Last update:2023-02-18, 1401/11/29
Update count:0
Registration date
2023-02-18, 1401/11/29
Registrant information
Name
Nazila Keshavarz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3646 8641
Email address
nazilakeshavarz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-01, 1401/04/10
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
2022-08-21, 1401/05/30
Actual recruitment end date
2022-09-21, 1401/06/30
Trial completion date
2022-09-21, 1401/06/30
Scientific title
The radioprotective effect of oral nanocurcumin in thyroid cancer patients after high dose radioactive iodine administration by examining the amount of inflamatory factor TNFα by ELISA test in patients blood serum
Public title
clinical
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient informed satisfaction
dose received by patients should be between 150 to 200 mci
patients should be 24 to 79 years old
Exclusion criteria:
Age
From 24 years old to 79 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
44
More than 1 sample in each individual
Number of samples in each individual:
2
In order to evaluate the inflammatory factor ,blood samples are taken and evaluated once before the radiopharmaceutical and once a week after the treatment.
Actual sample size reached:
44
More than 1 sample in each individual
Actual sample size in each individual:
2
In order to evaluate the inflammatory factor ,blood samples are taken and evaluated once before the radiopharmaceutical and once a week after the treatment.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple way, so that one of the study groups
are considered to be lions and the other group to be lines, and based on the desired sample size, the same number
A coin is tossed and people are randomly assigned to two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is one-way blinded and the study participants are blinded to the intervention in such a way that the placebo is prepared from drug-colored capsules containing a little starch and the patients do not know whether they are receiving the drug or the placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics com Emittee of Shiraz University of Medical Sciences
Street address
namazi hospital
City
Shiraz
Province
Fars
Postal code
714678813
Approval date
2022-06-25, 1401/04/04
Ethics committee reference number
IR.SUMS.REC.1401.207
Health conditions studied
1
Description of health condition studied
Thyroid cancer
ICD-10 code
C75.0
ICD-10 code description
Malignant neoplasm of parathyroid gland
Primary outcomes
1
Description
TNF factor
Timepoint
evaluate the inflammatory factor ,blood samples are taken and evaluated once before the radiopharmaceutical and once a week after the treatment.
Method of measurement
Eliza reader
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Considering that our goal is to be able to use the results of the study to improve the harmful effects caused by radiation in the treatment of patients, therefore, the nanomicelle curcumin sample of Erin Salamat Sina Company approved by the Ministry of Health as a dietary supplement with a dose of 40 mg of nano curcumin that is consumed These capsules are allowed to be taken one per day. Therefore, in order to conduct this study, one capsule per day will be prescribed according to the standard drug protocol three days before and seven days after the treatment.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
ahmad hoseynzadeh
Street address
Namazi SQUARE ,Namazi Hospital
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3612 5258
Email
nemazee_inf@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vahid Hoseyni
Street address
Zand Street. Central Building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
seyed Mohammad javad mortazavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Radiobiology and Radio safety
Street address
Shiraz, Zand Street, Imam Hossein Square, Shiraz Medical Faculty
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۵۷۹۴
Phone
+98 71 3230 3544
Email
mortazavismj@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
seyed Mohammad javad mortazavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Radiobiology and Radio safety
Street address
Shiraz, Zand Street, Imam Hossein Square, Shiraz Medical Faculty
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۵۷۹۴
Phone
+98 71 3230 3544
Email
mortazavismj@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nazila Keshavarz
Position
Technoloby radiology
Latest degree
Bachelor
Other areas of specialty/work
Radiology
Street address
No 5 Abierdi Ave;chamran Blvd;Shiraz Town
City
Shiraz
Province
Fars
Postal code
71913311
Phone
+98 71 3646 8641
Fax
Email
nazilakeshavarz@sums.ac.ir
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
There is no further information.
Study Protocol
No - There is not 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