A Multicenter, Randomized, Controlled Trial for Assessing the Usefulness of Suppressing Thyroid Stimulating Hormone Target Levels after Thyroid Lobectomy in Low to Intermediate Risk Thyroid Cancer Patients (MASTER): A Study Protocol

Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroid cancer cases, the extent of resection during surgery h...

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Published inEndocrinology and Metabolism Vol. 36; no. 3; pp. 574 - 581
Main Authors Lee, Eun Kyung, Kang, Yea Eun, Park, Young Joo, Koo, Bon Seok, Chung, Ki-Wook, Ku, Eu Jeong, Won, Ho-Ryun, Yoo, Won Sang, Jeon, Eonju, Paek, Se Hyun, Lee, Yong Sang, Lim, Dong Mee, Suh, Yong Joon, Park, Ha Kyoung, Kim, Hyo-Jeong, Kim, Bo Hyun, Kim, Mijin, Kim, Sun Wook, Yi, Ka Hee, Park, Sue K., Jung, Eun-Jae, Choi, June Young, Bae, Ja Seong, Hong, Joon Hwa, Nam, Kee-Hyun, Lee, Young Ki, Yu, Hyeong Won, Go, Sujeong, Kang, Young Mi
Format Journal Article
LanguageEnglish
Published Korea (South) Korean Endocrine Society 01.06.2021
대한내분비학회
Subjects
Diseases of the endocrine glands. Clinical endocrinology
Humans
Multicenter Studies as Topic
Original
Prospective Studies
Quality of Life
Randomized Controlled Trials as Topic
RC648-665
recurrence
Thyroid neoplasms
Thyroid Neoplasms - drug therapy
Thyroid Neoplasms - surgery
thyroidectomy
Thyrotropin
thyroxine
내과학
Thyroid neoplasms
Recurrence
Thyrotropin
Thyroidectomy
Thyroxine
Online AccessGet full text
ISSN2093-596X
2093-5978
2093-5978
DOI10.3803/enm.2020.943

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Abstract Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroid cancer cases, the extent of resection during surgery has generally decreased. Therefore, questions have been raised about the efficacy and long-term side effects of TSH suppression therapy in patients who have undergone a lobectomy. This is a multicenter, prospective, randomized, controlled clinical trial in which 2,986 patients with papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. The principle of treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 μIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 μIU/mL. The dose of levothyroxine will be adjusted at each visit to maintain the target TSH level. The primary outcome is recurrence-free survival, as assessed by neck ultrasound every 6 to 12 months. Secondary endpoints include disease-free survival, overall survival, success rate in reaching the TSH target range, the proportion of patients with major cardiovascular diseases or bone metabolic disease, the quality of life, and medical costs. The follow-up period is 5 years. The results of this trial will contribute to establishing the optimal indication for TSH suppression therapy in low-risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of recurrence, metabolic complications, costs, and quality of life.
AbstractList Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroid cancer cases, the extent of resection during surgery has generally decreased. Therefore, questions have been raised about the efficacy and long-term side effects of TSH suppression therapy in patients who have undergone a lobectomy.BACKGROUNDPostoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroid cancer cases, the extent of resection during surgery has generally decreased. Therefore, questions have been raised about the efficacy and long-term side effects of TSH suppression therapy in patients who have undergone a lobectomy.This is a multicenter, prospective, randomized, controlled clinical trial in which 2,986 patients with papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. The principle of treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 μIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 μIU/mL. The dose of levothyroxine will be adjusted at each visit to maintain the target TSH level. The primary outcome is recurrence-free survival, as assessed by neck ultrasound every 6 to 12 months. Secondary endpoints include disease-free survival, overall survival, success rate in reaching the TSH target range, the proportion of patients with major cardiovascular diseases or bone metabolic disease, the quality of life, and medical costs. The follow-up period is 5 years.METHODSThis is a multicenter, prospective, randomized, controlled clinical trial in which 2,986 patients with papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. The principle of treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 μIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 μIU/mL. The dose of levothyroxine will be adjusted at each visit to maintain the target TSH level. The primary outcome is recurrence-free survival, as assessed by neck ultrasound every 6 to 12 months. Secondary endpoints include disease-free survival, overall survival, success rate in reaching the TSH target range, the proportion of patients with major cardiovascular diseases or bone metabolic disease, the quality of life, and medical costs. The follow-up period is 5 years.The results of this trial will contribute to establishing the optimal indication for TSH suppression therapy in low-risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of recurrence, metabolic complications, costs, and quality of life.CONCLUSIONThe results of this trial will contribute to establishing the optimal indication for TSH suppression therapy in low-risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of recurrence, metabolic complications, costs, and quality of life.
Background Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroid cancer cases, the extent of resection during surgery has generally decreased. Therefore, questions have been raised about the efficacy and long-term side effects of TSH suppression therapy in patients who have undergone a lobectomy. Methods This is a multicenter, prospective, randomized, controlled clinical trial in which 2,986 patients with papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. The principle of treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 μIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 μIU/mL. The dose of levothyroxine will be adjusted at each visit to maintain the target TSH level. The primary outcome is recurrence-free survival, as assessed by neck ultrasound every 6 to 12 months. Secondary endpoints include disease-free survival, overall survival, success rate in reaching the TSH target range, the proportion of patients with major cardiovascular diseases or bone metabolic disease, the quality of life, and medical costs. The follow-up period is 5 years. Conclusion The results of this trial will contribute to establishing the optimal indication for TSH suppression therapy in low-risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of recurrence, metabolic complications, costs, and quality of life.
Background: Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroidcancer cases, the extent of resection during surgery has generally decreased. Therefore, questions have been raised about the efficacy and long-term side effects of TSH suppression therapy in patients who have undergone a lobectomy. Methods: This is a multicenter, prospective, randomized, controlled clinical trial in which 2,986 patients with papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. Theprinciple of treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 μIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 μIU/mL. The dose of levothyroxine will be adjusted at each visit to maintain the target TSH level. The primary outcome is recurrence-free survival, as assessed by neck ultrasound every 6 to 12months. Secondary endpoints include disease-free survival, overall survival, success rate in reaching the TSH target range, the proportion of patients with major cardiovascular diseases or bone metabolic disease, the quality of life, and medical costs. The followup period is 5 years. Conclusion: The results of this trial will contribute to establishing the optimal indication for TSH suppression therapy in low-risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of recurrence, metabolic complications, costs, and quality of life. KCI Citation Count: 1
Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroid cancer cases, the extent of resection during surgery has generally decreased. Therefore, questions have been raised about the efficacy and long-term side effects of TSH suppression therapy in patients who have undergone a lobectomy. This is a multicenter, prospective, randomized, controlled clinical trial in which 2,986 patients with papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. The principle of treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 μIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 μIU/mL. The dose of levothyroxine will be adjusted at each visit to maintain the target TSH level. The primary outcome is recurrence-free survival, as assessed by neck ultrasound every 6 to 12 months. Secondary endpoints include disease-free survival, overall survival, success rate in reaching the TSH target range, the proportion of patients with major cardiovascular diseases or bone metabolic disease, the quality of life, and medical costs. The follow-up period is 5 years. The results of this trial will contribute to establishing the optimal indication for TSH suppression therapy in low-risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of recurrence, metabolic complications, costs, and quality of life.
Author Ki-Wook Chung
Hyeong Won Yu
Young Mi Kang
Ja Seong Bae
Hyo-Jeong Kim
Dong Mee Lim
Young Joo Park
Eonju Jeon
Ka Hee Yi
Ho-Ryun Won
Yea Eun Kang
Se Hyun Paek
Yong Sang Lee
Sun Wook Kim
Young Ki Lee
Bo Hyun Kim
Mijin Kim
June Young Choi
Eun Kyung Lee
Sujeong Go
Kee-Hyun Nam
Eun-Jae Jung
Ha Kyoung Park
Joon Hwa Hong
Won Sang Yoo
Eu Jeong Ku
Sue K. Park
Bon Seok Koo
Yong Joon Suh
AuthorAffiliation 5 Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
16 Department of Internal Medicine, Pusan National University Hospital, Busan, Korea
3 Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea
4 Department of Otorhinolaryngology-Head and Neck Surgery, Chungnam National University College of Medicine, Daejeon, Korea
13 Department of Breast and Endocrine Surgery, Hallym University Sacred Heart Hospital, Anyang, Korea
21 Convergence Graduate Program in Innovative Medical Science, Seoul, Korea
9 Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea
25 Department of Internal Medicine, Daejeon Eulji Medical Center, Eulji University, Daejeon, Korea
10 Department of Surgery, Ewha Womans University School of Medicine, Seoul, Korea
22 Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University College of Medicine, Seoul, Korea
26 Department of Surgery, Yonsei
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ContentType Journal Article
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Hyeong Won Yu
Young Mi Kang
Sue K Park
Ja Seong Bae
Hyo-Jeong Kim
Dong Mee Lim
Young Joo Park
Eonju Jeon
Ka Hee Yi
Ho-Ryun Won
Yea Eun Kang
Nam, Kee Hyun
Se Hyun Paek
Yong Sang Lee
Sun Wook Kim
Young Ki Lee
Bo Hyun Kim
Mijin Kim
June Young Choi
Eun Kyung Lee
Sujeong Go
Kee-Hyun Nam
Eun-Jae Jung
Ha Kyoung Park
Joon Hwa Hong
Won Sang Yoo
Eu Jeong Ku
Bon Seok Koo
Yong Joon Suh
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Copyright Copyright © 2021 Korean Endocrine Society 2021
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Issue 3
Keywords Thyroid neoplasms
Recurrence
Thyrotropin
Thyroidectomy
Thyroxine
Language English
License This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
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These authors contributed equally to this work.
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PublicationTitle Endocrinology and Metabolism
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Snippet Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer...
Background Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated...
Background: Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated...
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SubjectTerms Diseases of the endocrine glands. Clinical endocrinology
Humans
Multicenter Studies as Topic
Original
Prospective Studies
Quality of Life
Randomized Controlled Trials as Topic
RC648-665
recurrence
Thyroid neoplasms
Thyroid Neoplasms - drug therapy
Thyroid Neoplasms - surgery
thyroidectomy
Thyrotropin
thyroxine
내과학
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Title A Multicenter, Randomized, Controlled Trial for Assessing the Usefulness of Suppressing Thyroid Stimulating Hormone Target Levels after Thyroid Lobectomy in Low to Intermediate Risk Thyroid Cancer Patients (MASTER): A Study Protocol
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