Thyroid Hormone Replacement After Radio Iodine: Value and Efficacy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversity Medical Center Groningen
About this trial
This study will be a multicentre prospective cohort study on TH-substitution after thyroid hormone withdrawal preceding radioiodine treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnancy
Patients with comorbidities, such as severe heart failure, (poorly controlled) atrial fibrillation, of which the treating physician decides that L-T3 is unsuitable.
Patients with a history of atrophic gastritis
Patients using proton-pomp inhibitors
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Euthyrox (levothyroxine)
DrugEuthyrox (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.
Cytomel (liothyronine)
DrugCytomel (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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: TH-combination cohort1 intervention
Group B: Levothyroxine cohort1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Before and after 2 weeks of TH-substitutionSecondary outcomes
1
TSH (mU/L)
The % of decrease of serum thyroid parameters TSH after 1, 2, 4, 6, and 12 weeks of TH-substitution.
Time frame
Before and after 1, 2, 4, 6, and 12 weeks of TH-substitution.2
Thyroglobulin (Tg; ng/mL)
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.
Time frame
Before and after 1, 2, 4, 6, and 12 weeks of TH-substitution3
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).
Time frame
Before and after 2, 6, and 12 weeks of TH-substitution4
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.
Time frame
Before and after 6 and 12 weeks of TH-substitutionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Medical Center Groningen
Lead sponsor
Radboud University Medical Center
Collaborator
Source ClinicalTrials.gov
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