The effect of selenium supplementation on sonographic findings of salivary glands in papillary thyroid cancer (PTC) patients treated with radioactive iodine: study protocol for a double-blind, randomized, placebo-controlled clinical trial
Abstract Background Thyroid cancer is a very damaging disease. The most common treatment for this disease includes thyroidectomy and then using radioactive iodine (RAI). RAI has many side effects, including a decrease in salivary secretions, followed by dry mouth and oral and dental injuries, as wel...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-08-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07470-2 |
| _version_ | 1797556664995414016 |
|---|---|
| author | Sepide Amini Marjan Golshani Masoud Moslehi Somayeh Hajiahmadi Gholamreza Askari Bijan Iraj Mohammad Bagherniya |
| author_facet | Sepide Amini Marjan Golshani Masoud Moslehi Somayeh Hajiahmadi Gholamreza Askari Bijan Iraj Mohammad Bagherniya |
| author_sort | Sepide Amini |
| collection | DOAJ |
| description | Abstract Background Thyroid cancer is a very damaging disease. The most common treatment for this disease includes thyroidectomy and then using radioactive iodine (RAI). RAI has many side effects, including a decrease in salivary secretions, followed by dry mouth and oral and dental injuries, as well as increased inflammation and oxidative stress. Selenium can be effective in these patients by improving inflammation and oxidative stress and by modulating salivary secretions. So far, only one clinical trial has investigated the effect of selenium on thyroid cancer patients treated with radioiodine therapy (RIT) conducted on 16 patients; considering the importance of this issue, to show the potential efficacy of selenium in these patients, more high-quality trials with a larger sample size are warranted. Methods This is a parallel double-blind randomized controlled clinical trial that includes 60 patients aged 20 to 65 years with papillary thyroid cancer (PTC) treated with RAI and will be conducted in Seyyed al-Shohada Center, an academic center for referral of patients to receive iodine, Isfahan, Iran. Thirty patients will receive 200 µg of selenium for 10 days (3 days before to 6 days after RAI treatment) and another 30 patients will receive a placebo for the same period. Sonographic findings of major salivary glands, salivary secretions, and sense of taste will be evaluated before and 6 months after 10-day supplementation. Discussion Due to its anti-inflammatory and antioxidant effects, as well as improving salivary secretions, selenium may improve the symptoms of thyroid cancer treated with radioactive iodine. In past studies, selenium consumption has not reduced the therapeutic effects of radiation therapy, and at a dose of 300 to 500 μg/day, it has not had any significant side effects in many types of cancer under radiation therapy. Trial registration Iranian Registry of Clinical Trials IRCT20201129049534N6 . Registered on 16 September 2021. |
| first_indexed | 2024-03-10T17:06:05Z |
| format | Article |
| id | doaj.art-9d94826546a2494796d5dee645b98a83 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-10T17:06:05Z |
| publishDate | 2023-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-9d94826546a2494796d5dee645b98a832023-11-20T10:49:28ZengBMCTrials1745-62152023-08-0124111110.1186/s13063-023-07470-2The effect of selenium supplementation on sonographic findings of salivary glands in papillary thyroid cancer (PTC) patients treated with radioactive iodine: study protocol for a double-blind, randomized, placebo-controlled clinical trialSepide Amini0Marjan Golshani1Masoud Moslehi2Somayeh Hajiahmadi3Gholamreza Askari4Bijan Iraj5Mohammad Bagherniya6Nutrition and Food Security Research Center and Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical SciencesDepartment of Internal Medicine, School of Medicine, Isfahan University of Medical SciencesDepartment of Medical Physics, School of Medicine, Isfahan University of Medical SciencesDepartment of Radiology, Isfahan University of Medical SciencesNutrition and Food Security Research Center and Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical SciencesIsfahan Endocrine and Metabolism Research Center, Isfahan University of Medical SciencesNutrition and Food Security Research Center and Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical SciencesAbstract Background Thyroid cancer is a very damaging disease. The most common treatment for this disease includes thyroidectomy and then using radioactive iodine (RAI). RAI has many side effects, including a decrease in salivary secretions, followed by dry mouth and oral and dental injuries, as well as increased inflammation and oxidative stress. Selenium can be effective in these patients by improving inflammation and oxidative stress and by modulating salivary secretions. So far, only one clinical trial has investigated the effect of selenium on thyroid cancer patients treated with radioiodine therapy (RIT) conducted on 16 patients; considering the importance of this issue, to show the potential efficacy of selenium in these patients, more high-quality trials with a larger sample size are warranted. Methods This is a parallel double-blind randomized controlled clinical trial that includes 60 patients aged 20 to 65 years with papillary thyroid cancer (PTC) treated with RAI and will be conducted in Seyyed al-Shohada Center, an academic center for referral of patients to receive iodine, Isfahan, Iran. Thirty patients will receive 200 µg of selenium for 10 days (3 days before to 6 days after RAI treatment) and another 30 patients will receive a placebo for the same period. Sonographic findings of major salivary glands, salivary secretions, and sense of taste will be evaluated before and 6 months after 10-day supplementation. Discussion Due to its anti-inflammatory and antioxidant effects, as well as improving salivary secretions, selenium may improve the symptoms of thyroid cancer treated with radioactive iodine. In past studies, selenium consumption has not reduced the therapeutic effects of radiation therapy, and at a dose of 300 to 500 μg/day, it has not had any significant side effects in many types of cancer under radiation therapy. Trial registration Iranian Registry of Clinical Trials IRCT20201129049534N6 . Registered on 16 September 2021.https://doi.org/10.1186/s13063-023-07470-2SeleniumThyroid cancerRadioactive iodineSalivary glandsSupplementation |
| spellingShingle | Sepide Amini Marjan Golshani Masoud Moslehi Somayeh Hajiahmadi Gholamreza Askari Bijan Iraj Mohammad Bagherniya The effect of selenium supplementation on sonographic findings of salivary glands in papillary thyroid cancer (PTC) patients treated with radioactive iodine: study protocol for a double-blind, randomized, placebo-controlled clinical trial Trials Selenium Thyroid cancer Radioactive iodine Salivary glands Supplementation |
| title | The effect of selenium supplementation on sonographic findings of salivary glands in papillary thyroid cancer (PTC) patients treated with radioactive iodine: study protocol for a double-blind, randomized, placebo-controlled clinical trial |
| title_full | The effect of selenium supplementation on sonographic findings of salivary glands in papillary thyroid cancer (PTC) patients treated with radioactive iodine: study protocol for a double-blind, randomized, placebo-controlled clinical trial |
| title_fullStr | The effect of selenium supplementation on sonographic findings of salivary glands in papillary thyroid cancer (PTC) patients treated with radioactive iodine: study protocol for a double-blind, randomized, placebo-controlled clinical trial |
| title_full_unstemmed | The effect of selenium supplementation on sonographic findings of salivary glands in papillary thyroid cancer (PTC) patients treated with radioactive iodine: study protocol for a double-blind, randomized, placebo-controlled clinical trial |
| title_short | The effect of selenium supplementation on sonographic findings of salivary glands in papillary thyroid cancer (PTC) patients treated with radioactive iodine: study protocol for a double-blind, randomized, placebo-controlled clinical trial |
| title_sort | effect of selenium supplementation on sonographic findings of salivary glands in papillary thyroid cancer ptc patients treated with radioactive iodine study protocol for a double blind randomized placebo controlled clinical trial |
| topic | Selenium Thyroid cancer Radioactive iodine Salivary glands Supplementation |
| url | https://doi.org/10.1186/s13063-023-07470-2 |
| work_keys_str_mv | AT sepideamini theeffectofseleniumsupplementationonsonographicfindingsofsalivaryglandsinpapillarythyroidcancerptcpatientstreatedwithradioactiveiodinestudyprotocolforadoubleblindrandomizedplacebocontrolledclinicaltrial AT marjangolshani theeffectofseleniumsupplementationonsonographicfindingsofsalivaryglandsinpapillarythyroidcancerptcpatientstreatedwithradioactiveiodinestudyprotocolforadoubleblindrandomizedplacebocontrolledclinicaltrial AT masoudmoslehi theeffectofseleniumsupplementationonsonographicfindingsofsalivaryglandsinpapillarythyroidcancerptcpatientstreatedwithradioactiveiodinestudyprotocolforadoubleblindrandomizedplacebocontrolledclinicaltrial AT somayehhajiahmadi theeffectofseleniumsupplementationonsonographicfindingsofsalivaryglandsinpapillarythyroidcancerptcpatientstreatedwithradioactiveiodinestudyprotocolforadoubleblindrandomizedplacebocontrolledclinicaltrial AT gholamrezaaskari theeffectofseleniumsupplementationonsonographicfindingsofsalivaryglandsinpapillarythyroidcancerptcpatientstreatedwithradioactiveiodinestudyprotocolforadoubleblindrandomizedplacebocontrolledclinicaltrial AT bijaniraj theeffectofseleniumsupplementationonsonographicfindingsofsalivaryglandsinpapillarythyroidcancerptcpatientstreatedwithradioactiveiodinestudyprotocolforadoubleblindrandomizedplacebocontrolledclinicaltrial AT mohammadbagherniya theeffectofseleniumsupplementationonsonographicfindingsofsalivaryglandsinpapillarythyroidcancerptcpatientstreatedwithradioactiveiodinestudyprotocolforadoubleblindrandomizedplacebocontrolledclinicaltrial AT sepideamini effectofseleniumsupplementationonsonographicfindingsofsalivaryglandsinpapillarythyroidcancerptcpatientstreatedwithradioactiveiodinestudyprotocolforadoubleblindrandomizedplacebocontrolledclinicaltrial AT marjangolshani effectofseleniumsupplementationonsonographicfindingsofsalivaryglandsinpapillarythyroidcancerptcpatientstreatedwithradioactiveiodinestudyprotocolforadoubleblindrandomizedplacebocontrolledclinicaltrial AT masoudmoslehi effectofseleniumsupplementationonsonographicfindingsofsalivaryglandsinpapillarythyroidcancerptcpatientstreatedwithradioactiveiodinestudyprotocolforadoubleblindrandomizedplacebocontrolledclinicaltrial AT somayehhajiahmadi effectofseleniumsupplementationonsonographicfindingsofsalivaryglandsinpapillarythyroidcancerptcpatientstreatedwithradioactiveiodinestudyprotocolforadoubleblindrandomizedplacebocontrolledclinicaltrial AT gholamrezaaskari effectofseleniumsupplementationonsonographicfindingsofsalivaryglandsinpapillarythyroidcancerptcpatientstreatedwithradioactiveiodinestudyprotocolforadoubleblindrandomizedplacebocontrolledclinicaltrial AT bijaniraj effectofseleniumsupplementationonsonographicfindingsofsalivaryglandsinpapillarythyroidcancerptcpatientstreatedwithradioactiveiodinestudyprotocolforadoubleblindrandomizedplacebocontrolledclinicaltrial AT mohammadbagherniya effectofseleniumsupplementationonsonographicfindingsofsalivaryglandsinpapillarythyroidcancerptcpatientstreatedwithradioactiveiodinestudyprotocolforadoubleblindrandomizedplacebocontrolledclinicaltrial |