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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511668-10-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Radboud University Medical Center | OTHER |
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This study will be a multicentre prospective cohort study on TH-substitution after thyroid hormone withdrawal preceding radioiodine treatment.
While treatment with L-T4 after TH-withdrawal is widely used in DTC patients to suppress TSH and improve hypothyroid symptoms, the value of L-T3 addition in initiation of TH treatment has not been evaluated in this context. Lifelong monotherapy with L-T3 should not be preferred over L-T4 yet, short-term use of L-T3 to initiate TH-supplementation can be safely implemented. We hypothesize that initial treatment with L-T4+L-T3 combination treatment can have a more direct effect on TSH-levels and earlier relieve of hypothyroid symptoms resulting in a better QoL. We will conduct a prospective cohort study comparing the initiation of TH-supplementation after TH-withdrawal in two cohorts of DTC patients: patients receiving L-T4+LT3 with a gradually decrease of L-T3 dose in time, and patients receiving L-T4 only. We will compare potency to suppress TSH, effect on QoL and effects on thyroid- and cardiovascular parameters. Patients (18-75 years) diagnosed with high-risk DTC after TH-withdrawal will be eligible for inclusion. The primary objective is to compare the proportion of patients reaching target TSH-levels after two weeks of substitution with L-T3 or L-T4.
Secondary objectives are to compare the effects of L-T4+L-T3 or L-T4 in the first 3 months of treatment on serum thyroid parameters TSH and Tg, quality of life, and cardiovascular parameters
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TH-combination cohort | L-T4+L-T3 combination according to local protocol. |
| |
| Levothyroxine cohort | L-T4 monotherapy according to local protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Euthyrox (levothyroxine) | Drug | Euthyrox (levothyroxine sodium tablets; L-T4) is a thyromimetic synthetic drug identical to T4. Patients will recieve levothyroxine (euthyrox) in a dose of 2 μg × kg body weight / day. |
| Measure | Description | Time Frame |
|---|---|---|
| TSH after two weeks of TH substitution | The percentage of patients reaching target TSH (<0.5 mU/L) after two weeks of L-T3+L-T4 substitution compared to patients with L-T4-substitution. | Before and after 2 weeks of TH-substitution |
| Measure | Description | Time Frame |
|---|---|---|
| TSH (mU/L) | The % of decrease of serum thyroid parameters TSH after 1, 2, 4, 6, and 12 weeks of TH-substitution. | Before and after 1, 2, 4, 6, and 12 weeks of TH-substitution. |
| Thyroglobulin (Tg; ng/mL) |
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Inclusion Criteria:
Exclusion Criteria:
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This study will include patients with a histologically confirmed high-risk DTC, men and women aged 18-75 years. Patients have to be prepared to RAI with TH-withdrawal and treated according to the ATA guidelines.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mirthe Links, BSc | Contact | +31 50 3610973 | m.h.links@umcg.nl | |
| Wouter Zandee, MD/PhD | Contact | +31 50 3613731 | w.t.zandee@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Wouter Zandee, MD/PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen (UMCG) | Groningen | Provincie Groningen | 9700RB | Netherlands |
Handling of personal data complies with the General Data Protection Regulation (GDPR; in Dutch: De uitvoeringswet algemene verorderning gegevensbescherming [UAVG]). Encoded data will be kept for 15 years after closure of the study and can only be used for ancillary studies after strict approval of the study protocol by the project leader (dr. W. Zandee).
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| D014284 | Triiodothyronine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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Blood samples from venapuncture
| Cytomel (liothyronine) | Drug | Cytomel (liothyronine sodium tablets; L-T3) is a thyromimetic synthetic drug identical to T3. The patients in this cohort recieve L-T4+L-T3 combination therapy. The L-T4 dose will be 2 μg × kg body weight / day, equal to the dose in the other interventional arm. L-T3 will be added twice daily from the first day of combination treatment, in dosages gradually decreasing from 25 ug 2/day to 5 ug 2/day over a time span of 3 weeks after which L-T3 is stopped. |
|
The % of decrease of serum thyroid parameters Tg after 1, 2, 4, 6, and 12 weeks of TH-substitution.
Tg is a precursor of T3 and T4 and is a measurement for remaining thyroid (cancer) cells. Tg-levels are affected by TSH and therefore, we expect by reducing TSH-levels to also reduce Tg levels. Consecutive Tg-measurements in this study act as a secondary measure for TH substitution. Since Tg-values between patients variable, we will use the % decrease instead of absolute values.
| Before and after 1, 2, 4, 6, and 12 weeks of TH-substitution |
| QoL in patients treated with L-T3 or L-T4 | Quality of life will be assessed using standardized QoL questionnaires for thyroid- and thyroid cancer patient reported outcome. Our aim is to compare improvement of hypothyroid symptoms after initiation of therapy, and evaluate whether sings of hyperthyroidism and possible overtreatment are present. We will use the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (core measure QoL questionnaire) in combination with the THYCA-QoL (additional thyroid cancer-specific part). | Before and after 2, 6, and 12 weeks of TH-substitution |
| Heart rate (HR; bpm) | Cardiovascular parameters will be assessed during visits to the outpatient clinic before initiation of TH-substitution (during hypothyroidism) and after 6 weeks of TH-treatment. Patients will be compared intra- and interindividually. | Before and after 6 and 12 weeks of TH-substitution |
| Blood pressure (BP; mmHg) | Cardiovascular parameters will be assessed during visits to the outpatient clinic before initiation of TH-substitution (during hypothyroidism) and after 6 and 12 weeks of TH-treatment. Patients will be compared intra- and interindividually. | Before and after 6 and 12 weeks of TH-substitution |
| Radboud University Nijmegen | Nijmegen | Netherlands |
|
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013970 | Thyronines |