Investigation of the effects of omega-3 fatty acids on Th1/Th2/Th9/Th17/Th22 cytokines in patients with differentiated thyroid cancer under the treatment with radioiodine
Determination of omega-3 effects on 13 cytokines belong to different T cell subsets including Th1/Th2/ Th9 /Th17/Th22 in patients with differentiated thyroid cancer under the treatment with radioiodine
Design
In G2, the first blood sample was collected 1 month before RAI ablation. Then patients started to take omega-3 for 30 days and the second blood sample was collected immediately before RAI ablation. The third and fourth blood samples were collected one week and one month after RAI ablation, respectively. In G1 and G3, blood samples were collected immediately before RAI ablation as well as one week and one month after RAI ablation. Serum was isolated from each blood sample and stored at −20°C. Cytokine assays was done with cytometric bead-based assay.
Settings and conduct
Shiraz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Adult patients with DTC who had total or near-total thyroidectomy and planned to treat with radioiodine with 100 or 150 mCi
Intervention groups
The patients with DTC were divided into two groups based on RAI dosage: high dose with 150 mCi and intermediate dose with 100 mCi. Then patients in each group was randomly divided into three subgroups: G1 with RAI ablation only, G2 treated with omega-3 for 30 days before RAI ablation, and G3 treated with omega-3 for 30 days after RAI ablation.
Main outcome variables
Cytokine change
General information
Reason for update
Acronym
DTC, RAI
IRCT registration information
IRCT registration number:IRCT20220104053622N1
Registration date:2022-02-05, 1400/11/16
Registration timing:retrospective
Last update:2022-02-05, 1400/11/16
Update count:0
Registration date
2022-02-05, 1400/11/16
Registrant information
Name
Shirin Farjadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3235 1575
Email address
farjadsh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-09, 1398/11/20
Expected recruitment end date
2021-02-08, 1399/11/20
Actual recruitment start date
2020-02-09, 1398/11/20
Actual recruitment end date
2021-05-10, 1400/02/20
Trial completion date
2021-05-10, 1400/02/20
Scientific title
Investigation of the effects of omega-3 fatty acids on Th1/Th2/Th9/Th17/Th22 cytokines in patients with differentiated thyroid cancer under the treatment with radioiodine
Public title
Investigation of the effects of omega-3 on immune system in patients with thyroid cancer under the treatment with radioiodine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Involving with differentiated thyroid cancer
Adult patients
Total or near-total thyroidectomy
Planned for radioiodine ablation with 150 mCi or 100 mCi
Exclusion criteria:
Patients who will be received radioiodine at doses higher than 150 mCi
Patients who were previously received radioiodine
Patients who had taken omega-3 or other supplements before the study
Patients who had undergone a second thyroid surgery
Patients who have other cancers
Patients who have concurrent chronic inflammatory disease
Patients who have autoimmune disease or other cancers
Age
From 18 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
90
More than 1 sample in each individual
Number of samples in each individual:
4
- In G2: The first blood sample was taken one month before RAI. The second sample was taken 30 days after taking omega-3 and just before RAI. The third and forth samples were taken one week and one month after RAI. - In G1 and G3: The first blood sample was taken just before RAI. The second and third samples were taken one week and one month after RAI. - Just one blood sample was taken from each individual in normal control group.
Actual sample size reached:
100
More than 1 sample in each individual
Actual sample size in each individual:
4
In G2: The first blood sample was taken one month before RAI. The second sample was taken 30 days after taking omega-3 and just before RAI. The third and forth samples were taken one week and one month after RAI. In G1 and G3: The first blood sample was taken just before RAI. The second and third samples were taken one week and one month after RAI. - Just one blood sample was taken from each individual in normal control group.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Because immunological factors are varied based on age and gender, in this study patients were nonrandomized allocated into different subgroups as their distribution were age and sex matched. Patients with UTC were divided into two groups based on RAI dose (100 and 150 mCi) determined by nuclear medicine specialist. Then patients in each group were divided into three subgroups nonrandomly as their distribution were age and sex matched: - Patients who received RAI (G1) - Patients who received omega-3 before RAI (G2) - Patients who received omega-3 after RAI (G3) A group of age and sex-matched healthy individuals with normal routine tests were selected as normal control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2020-02-02, 1398/11/13
Ethics committee reference number
IR.SUMS.REC.1398.1302
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
ICD-10 code description
cancer
Primary outcomes
1
Description
Cytokine change
Timepoint
30 days before RAI, Just before RAI, 7 & 30 days after RAI
Method of measurement
Cytometric bead-based assay
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who received omega-3 for 30 days before RAI therapy. - Based on radioiodine dosage, these patients were allocated in two groups with 100 mCi and 150 mCi. - These patients were instructed to take a soft-gel capsule of fish oil-derived omega-3 fatty acids (Best Formulations Inc., Los Angeles, CA, USA) containing 180 mg eicosapentaenoic acid and 120 mg docosahexaenoic acid daily for 30 consecutive days before RAI ablation.
Category
Treatment - Drugs
2
Description
Intervention group: Patients who received omega-3 for 30 days after RAI therapy. - Based on radioiodine dosage, These patients were allocated in two groups with 100 mCi and 150 mCi. - These Patients were instructed to take a soft-gel capsule of fish oil-derived omega-3 fatty acids (Best Formulations Inc., Los Angeles, CA, USA) containing 180 mg eicosapentaenoic acid and 120 mg docosahexaenoic acid daily for 30 consecutive days after RAI ablation.
Category
Treatment - Drugs
3
Description
Control group: Patients who received RAI therapy only. - Based on radioiodine dosage, these patients were allocated into two groups with 100 mCi and 150 mCi.
Category
Treatment - Other
4
Description
Normal controls group: Sex and age-matched individuals with no previous history of cancers and autoimmune diseases with no history of involvement with infectious disease in last month before sample collection and the results of their routine test were normal.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nuclear Medicine Department at Namazi Hospital affiliated with Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mehrosadat Alavi
Street address
Nuclear Medicine Department, Namazi Hospital.,
City
Shiraz
Province
Fars
Postal code
71348-45794
Phone
+98 71 3612 5317
Fax
Email
alavimh@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institute for Medical Research Development
Full name of responsible person
Dr. Reza Malekzadeh
Street address
Fatemi St.,
City
Tehran
Province
Tehran
Postal code
1419693111
Phone
+98 21 6693 8037
Fax
+98 21 6690 0920
Email
nimad.rms@research.ac.ir
Web page address
http://nimad.ac.ir
Grant name
Educated researcher grant (call 3)
Grant code / Reference number
958687
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development
Proportion provided by this source
99
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
2
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
ِDr. Younes Ghasemi
Street address
Zand st.,
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Fax
+98 71 3230 7594
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
National Institute for Research Development
Proportion provided by this source
1
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
Dr. Shirin Farjadian
Position
Prof. Of Immunology
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Zand St.,
City
Shiraz
Province
Fars
Postal code
71348-45794
Phone
+98 71 3235 2575
Fax
+98 917 702 4327
Email
farjadsh@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shirin Farjadian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Zand St.,
City
Shiraz
Province
Fars
Postal code
71348-45794
Phone
071 2351575
Email
farjadsh@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shirin Farjadian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
zand St.,
City
Shiraz
Province
Fars
Postal code
71348-45794
Phone
+98 71 3235 1575
Email
farjadsh@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Serum levels of 13 cytokines in each patient in different subgroups
When the data will become available and for how long
For ever
To whom data/document is available
Will be published as accessory file attached to the article
Under which criteria data/document could be used
Who has access to the full text of the article or ask the corresponding author via email
From where data/document is obtainable
Who refers to the full text of the article or through contact with the corresponding author
What processes are involved for a request to access data/document