Clinical trial to evaluate the role of radioprotection effect of curcumin in peripheral blood lymphocytes of patients with differentiated thyroid carcinoma treated with Iodine-131, by micronucleus assay
Objectives: There are several treatments in patients with thyroid cancer, one of the treatment after total thyroidectomy is radioiodine therapy, which has primary and late complications like genetic effects. In order to reduce the genetic effects Nano-curcumin supplements were used.
Design: The study was performed in patients with differentiated thyroid cancer who received the first dose of radioactive iodine after surgery.
Intervention: Patients were randomly divided into two groups.(Sample size = 20)
Group A patients receiving 150 mCi of iodine 131 with a daily dose of 160 mg of Nano-curcumin 3 days before radioiodine therapy up to 10 days.
Group B patients received treatment with 150 mCi of iodine 131 without a daily dose of Nano curcumin.
Participants: All patients with thyroid carcinoma that has not received an ablation dose of radioiodine; thyroid cancer confirmed by biopsy; all patients have total thyroidectomy; TSH level before the administration of radioiodine is higher than 30 IU/ML.
Method: a blood sample (5 cc) before treatment and 7 days after the administration of iodine taken and transferred to cytogenetic lab to evaluate genetic damages, at the end of study we compared two groups in reducing genetic damage with or without Nano-curcumin.
General information
Acronym
Differentiated Thyroid Carcinoma
IRCT registration information
IRCT registration number:IRCT2016020526377N1
Registration date:2016-04-19, 1395/01/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-19, 1395/01/31
Registrant information
Name
Maryam Farhadi
Name of organization / entity
Shahid Beheshti University of Medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 2387 2206
Email address
maryam.farhadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-04-25, 1394/02/05
Expected recruitment end date
2015-12-16, 1394/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to evaluate the role of radioprotection effect of curcumin in peripheral blood lymphocytes of patients with differentiated thyroid carcinoma treated with Iodine-131, by micronucleus assay
Public title
Radiation protection effect of curcumin in patients with thyroid cancer treated with 131-I
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients with differentiated thyroid cancer (follicular, papillary or mixed type) don't received destroying dose (ablative dose) of radioiodine up to now; no palpable neck mass; thyroid pathology reported there is no invasion to capsular and lymph areas and blood vessels; body scan with 131-I don’t show any functional tissue in regions other than the thyroid bed; thyroid cancer confirmed by biopsy; all patients have total thyroidectomy; TSH level before administration of radioiodine is higher than 30 IU/ML.
exclusion criteria: after treatment with 131 I if there is abnormal tissue absorption of iodine in other areas of the thyroid bed; if patients after taking the first capsule of curcumin had a headache and dizziness; patient will be excluded.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor For Research, Shahid Beheshti University of Medical Sciences
Street address
Faculty of Paramedical Sciences، Darband St، Qods Sq، Tehran، Iran
City
Tehran
Postal code
198396-3113
Approval date
2015-03-15, 1393/12/24
Ethics committee reference number
SBMU.REC.1393.797
Health conditions studied
1
Description of health condition studied
differentiated thyroid carcinoma(DTC)
ICD-10 code
C73
ICD-10 code description
Malignant neoplasm of thyroid gland
Primary outcomes
1
Description
MN counts in 1000 BN cells
Timepoint
before and 7 days after radioiodine therapy
Method of measurement
blood sampling
Secondary outcomes
1
Description
Lymphocyte and platelets count
Timepoint
before and 1 week after radioiodine therapy
Method of measurement
blood sample/ CBC
Intervention groups
1
Description
Group I: Nano-curcumin tablets, 80 mg orally, twice daily, for 10 days from 3 days before to seven days after radioiodine therapy
Category
Treatment - Drugs
2
Description
Group II: No nano-curcumin tablets
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Nuclear Medicine Center, Taleghani Hospital
Full name of responsible person
Dr. Babak Shafiei
Street address
Velenjak St, Shahid Chamran Highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mohsen Bakhshandeh
Street address
Darband St, Qods Sq, Paramedical Department
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Dr. Mohsen Bakhshandeh
Position
Medical Physic Phd
Other areas of specialty/work
Street address
Faculty of Paramedical Sciences، Darband St، Qods Sq، Tehran، Iran
City
Tehran
Postal code
19711653313
Phone
+98 21 2271 7503
Fax
Email
mbakhshandeh@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Maryam Farhadi
Position
Ms Student of Radiobiology and Radiation Protection
Other areas of specialty/work
Street address
Faculty of Paramedical Sciences، Darband St، Qods Sq، Tehran، Iran
City
Tehran
Postal code
Phone
+98 21 2271 7503
Fax
Email
maryam.farhadi@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Scinece
Full name of responsible person
Maryam Farhadi
Position
Ms Student of Radiobiology
Other areas of specialty/work
Street address
Faculty of Paramedical Sciences، Darband St، Qods Sq، Tehran، Iran
City
Tehran
Postal code
19711653313
Phone
00
Fax
Email
mary.frd1990@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)