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IRCT20220104053622N1 IRCT 2022-02-05 National Institute for Medical Research Development Investigation of the effects of omega-3 on immune system in patients with thyroid cancer under the treatment with radioiodine DTC, RAI 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 2020-02-09 anticipated 90 Complete https://irct.ir/trial/61153 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. 4 cancer. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Intervention 4: 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. Yes - There is a plan to make this available What will be shared: Serum levels of 13 cytokines in each patient in different subgroups When: For ever To whom: Will be published as accessory file attached to the article Conditions: Who has access to the full text of the article or ask the corresponding author via email Where to obtain: Who refers to the full text of the article or through contact with the corresponding author How to obtain: Send an email to the corresponding author Comments:
public Dr. Shirin Farjadian
Zand St.,
Shiraz Iran (Islamic Republic of) 71348-45794 +98 71 3235 2575 farjadsh@sums.ac.ir Shiraz University of Medical Sciences scientific Shirin Farjadian
Zand St.,
Shiraz Iran (Islamic Republic of) 71348-45794 071 2351575 farjadsh@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Involving with differentiated thyroid cancer Adult patients Total or near-total thyroidectomy Planned for radioiodine ablation with 150 mCi or 100 mCi 18 years 60 years Both 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 cancer Treatment - Drugs Treatment - Drugs Treatment - Other Other 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. 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. 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. 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. Cytokine change. Timepoint: 30 days before RAI, Just before RAI, 7 & 30 days after RAI. Method of measurement: Cytometric bead-based assay. Shiraz University of Medical Sciences National Institute for Medical Research Development National Institute for Research Development Approved 2020-02-02 Ethics Committee of Shiraz University of Medical Sciences Zand St. Shiraz Fars Iran (Islamic Republic of)