Clinical trial NCT04916262: Correlation Between TCM Syndrome Factors and TSH Changes of Thyroid Hormone Withdrawal Before Iodine Therapy in Postoperative Patients With Thyroid Cancer
Official title: Correlation Between TCM Syndrome Factors and TSH Changes of Thyroid Hormone Withdrawal Before Iodine Therapy in Postoperative Patients With Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Differentiated Thyroid Carcinoma
TCM Syndrome Type
Keywords: Differentiated Thyroid Carcinoma
TCM syndrome type
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with thyroid cancer who need 131I therapy after operation

Brief summary: The purpose of this study is to make a dialectical classification of patients who will receive 131I treatment after operation of thyroid cancer from the point of view of dialectics of syndrome elements of traditional Chinese medicine. By observing the changes of TSH among patients with different syndrome types, investigators can better understand the reasons for the differences in TSH changes among patients. Thus, it provides a basis for putting forward the scheme of stopping taking levothyroxine before iodine treatment, improving the quality of life of patients after radical thyroidectomy, and providing reference for individualized guidance of the timing of radioactive iodine therapy for patients after DTC.

Detailed description: Thyroid cancer is a common thyroid tumor. In the past few decades, the incidence of thyroid cancer in most parts of the world has increased steadily year by year. At present, the best treatment for differentiated thyroid cancer at home and abroad is surgery + radioactive iodine + thyroid hormone replacement inhibition.131I therapy, as an important adjuvant therapy for patients with DTC, can effectively remove the residual thyroid tissue and unresectable local and distant metastatic lesions during the operation.

It is considered that the level of TSH and the time of thyroid hormone withdrawal are important factors affecting the efficacy of radioiodine therapy, and there is a close relationship between the two factors. Clinically, investigators also observed that TSH changes were different in patients who were about to receive iodine treatment after DTC during the withdrawal of thyroxine. In some patients, TSH levels rise rapidly in a short period of time, while others rise slowly. For patients with rapid increase of TSH (sometimes even more than 100uIU/ml), it may promote tumor growth, recurrence and recessive metastasis. Patients with slow rise of TSH may need to constantly review thyroid function until reaching the standard, which brings inconvenience to patients, and withdrawal of drugs for too long will affect patients' physical, psychological and living conditions, resulting in patient discomfort.

In this study, the dialectical classification of TCM syndrome factors was carried out in the patients before radioiodine therapy after DTC. After collecting the patients who met the inclusion and exclusion criteria, they were divided into two groups according to TSH ≤ 30uIU/mL and TSH \> 30uIU/mL on the 14th day. The TCM syndrome elements and other clinical information of each group were collected respectively. Investigators will observe the changes of TSH in patients with different types of TCM syndrome factors, and gain a deeper understanding of the reasons for the differences in TSH changes. Investigators hope to provide a basis for putting forward a plan to stop thyroxine before iodine therapy, to improve the quality of life of postoperative patients with thyroid cancer, and to provide a reference for individualized guidance of the timing of radioactive iodine therapy for patients after DTC.

Eligibility criteria: Inclusion Criteria:

1. Study time: June 1, 2021, to January 1, 2022;
2. Study site: The First Affiliated Hospital of Shandong First Medical University;
3. 18-75 years old (including upper and lower limits), male or female;
4. Patients with differentiated thyroid carcinoma diagnosed pathologically after total thyroidectomy
5. Patients with oral levothyroxine tablets ≥ 4 weeks after operation
6. Patients who have stopped taking levothyroxine tablets and whose TSH \< 4.2uIU/ml at the time of withdrawal
7. Patients who meet the 131I treatment criteria

Exclusion Criteria:

1. Pregnant or lactating women
2. Patients with various mental disorders, unconscious, etc.
3. Cases with inaccurate information collection

Primary outcomes:
measure: Primary Outcome Measure 1
timeFrame: The data will be collected, analyzed and calculated in about 3 days.
measure: Primary Outcome Measure 2
timeFrame: The data will be collected, analyzed and calculated in about 3 days.
Secondary outcomes:
measure: Secondary Outcome Measure 1
timeFrame: 2 weeks.
measure: Secondary Outcome Measure 2
timeFrame: 2 weeks.
measure: Secondary Outcome Measure 3
timeFrame: 2 weeks.
measure: Secondary Outcome Measure 4
timeFrame: 2 weeks.
measure: Secondary Outcome Measure 5
timeFrame: 2 weeks.
measure: Secondary Outcome Measure 6
timeFrame: 2 weeks.
measure: Secondary Outcome Measure 7
timeFrame: 2 weeks.
measure: Secondary Outcome Measure 8
timeFrame: 2 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
name: Lin Liao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou Y, Yang Y, Zhou T, Li B, Wang Z. Adiponectin and Thyroid Cancer: Insight into the Association between Adiponectin and Obesity. Aging Dis. 2021 Apr 1;12(2):597-613. doi: 10.14336/AD.2020.0919. eCollection 2021 Apr.
citation: Stewart LA, Kuo JH. Advancements in the treatment of differentiated thyroid cancer. Ther Adv Endocrinol Metab. 2021 Mar 17;12:20420188211000251. doi: 10.1177/20420188211000251. eCollection 2021.
citation: Borges de Souza P, McCabe CJ. Radioiodine treatment: an historical and future perspective. Endocr Relat Cancer. 2021 Sep 3;28(10):T121-T124. doi: 10.1530/ERC-21-0037. No abstract available.
citation: Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.