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ClinicalTrials.gov ID

NCT06647602

Lead Sponsor

University Medical Center GroningenOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

40Estimated

Last Update Posted

Feb 10, 2026Actual

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Mar 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

Official Title

Thyroid Hormone Replacement After Radio Iodine: Value and Efficacy

Brief Summary

This study will be a multicentre prospective cohort study on TH-substitution after thyroid hormone withdrawal preceding radioiodine treatment.

Detailed Description

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

• Differentiated Thyroid Cancer
• Thyroid Cancer
• Levothyroxine
• Liothyronine
• Thyroid Hormones

• Euthyrox (levothyroxine)
• Cytomel (liothyronine)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Histologically confirmed DTC (papillary thyroid carcinoma, follicular thyroid carcinoma, oncocytic thyroid carcinoma)
• Classified as high-risk DTC according to the ATA guidelines or, patients for whom the risk of a recurrence is estimated to be higher based on clinical features (assessed by their treating physician).
• Prepared for RAI-therapy with TH-withdrawal
• Patients must be fit to adhere to the study protocol
• Patients must be able to read and understand the Dutch language

Exclusion Criteria:

• Pregnancy
• Patients with comorbidities, such as severe heart failure, (poorly controlled) atrial fibrillation, of which the treating physician decides that L-T3 is unsuitable.
• Conditions or drugs interfering with thyroid hormone uptake:
• Patients with a history of atrophic gastritis
• Patients using proton-pomp inhibitors

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

University Medical Center GroningenOTHER

Collaborators

Radboud University Medical CenterOTHER

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