Endocrinol Metab.  2021 Jun;36(3):574-581. 10.3803/EnM.2020.943.

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

Affiliations
  • 1Center for Thyroid Cancer, National Cancer Center, Goyang, Korea
  • 2Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea
  • 3Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea
  • 4Department of Otorhinolaryngology-Head and Neck Surgery, Chungnam National University College of Medicine, Daejeon, Korea
  • 5Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
  • 6Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Korea
  • 7Department of Otorhinolaryngology-Head and Neck Surgery, Chungnam National University Sejong Hospital, Sejong, Korea
  • 8Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea
  • 9Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea
  • 10Department of Surgery, Ewha Womans University School of Medicine, Seoul, Korea
  • 11Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
  • 12Department of Internal Medicine, Konyang University Hospital, Daejeon, Korea
  • 13Department of Breast and Endocrine Surgery, Hallym University Sacred Heart Hospital, Anyang, Korea
  • 14Department of Surgery, Inje University Busan Paik Hospital, Busan, Korea
  • 15Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University, Seoul, Korea
  • 16Department of Internal Medicine, Pusan National University Hospital, Busan, Korea
  • 17Division of Endocrinology & Metabolism, Department of Medicine, Thyroid Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
  • 18Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea
  • 19Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea
  • 20Cancer Research Institute, Seoul National University, Seoul, Korea
  • 21Convergence Graduate Program in Innovative Medical Science, Seoul National University College of Medicine, Seoul, Korea
  • 22Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University College of Medicine, Seoul, Korea
  • 23Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea
  • 24Department of Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 25Department of Internal Medicine, Daejeon Eulji Medical Center, Eulji University, Daejeon, Korea
  • 26Department of Surgery, Yonsei University College of Medicine, Seoul, Korea

Abstract

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.

Keyword

Thyroid neoplasms; Thyrotropin; Thyroxine; Recurrence; Thyroidectomy
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