Thyroid Hormone for Thyroid Cancer
- Conditions
- Differentiated Thyroid CancerThyroid CancerLevothyroxineLiothyronineThyroid Hormones
- Interventions
- Registration Number
- NCT06647602
- Lead Sponsor
- University Medical Center Groningen
- Brief Summary
This study will be a multicentre prospective cohort study on TH-substitution with liothyronine (L-T3) and levothyroxine (L-T4) in DTC patients after TH-withdrawal. The first cohort is patients treated in the University Medical Centre Groningen (UMCG) with L-T3 according to standard local protocol. The second cohort is patients treated in the Radboud University Medical Centre (Radboud UMC) with L-T4, also according to standard local protocol. We will compare effects of L-T3 or L-T4 on TSH, Thyroglobulin (Tg), quality of life (QoL), weight and cardiovascular parameters.
- 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 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-T3 can have a more rapid effect on TSH-levels and earlier relieve of hypothyroid symptoms resulting in a better QoL. To evaluate TH-supplementation with L-T3, we will conduct a prospective cohort study comparing the initiation of TH-supplementation after TH-withdrawal in two cohorts of DTC patients: patients treated in the University Medical Centre Groningen (UMCG) receiving L-T3 and patients treated in the Radboud University Medical Centre (Radboud UMC) receiving L-T4. 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 treated in the UMCG or Radboud UMC and receiving THST with L-T3 or L-T4 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-T3 and L-T4 in the first 6 months of treatment on serum thyroid parameters TSH and Tg, quality of life, weight, and cardiovascular parameters
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Histologically confirmed DTC (papillary thyroid carcinoma, follicular thyroid carcinoma, oncocytic thyroid carcinoma)
- Classified as high-risk DTC according to the ATA guidelines (1) 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 have to be fit to adhere to the study protocol
- Patients have to be able to read and understand the Dutch language
- Pregnancy
- Patients with a psychiatric history or history of depression
- 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 gastriti
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Liothyronine cohort Cytomel (liothyronine) Patients in the UMCG will receive L-T3 according to local protocol. Levothyroxine cohort Euthyrox (levothyroxine) Patients in the Radboud UMC will receive L-T4 according to local protocol.
- Primary Outcome Measures
Name Time Method TSH after two weeks of TH substitution Before and after 2 weeks of TH-substitution The primary outcome is the percentage of patients that reached target TSH-levels of \<0.10 mU/L after two weeks of L-T3-substitution compared to patients with L-T4-substitution.
- Secondary Outcome Measures
Name Time Method Body-mass index (BMI; Kg/m2) Before and after 6 and 24 weeks of TH-substitution Weight will be measured at home and reported by patients. BMI will be calculated from the weight in kilograms divided by height in meters squared.
Weight (Kg) Before and after 6 and 24 weeks of TH-substitution Weight will be measured at home and reported by patients. BMI will be calculated from the weight in kilograms divided by height in meters squared.
TSH (mU/L) Before and after 1, 2, 4, 6, 12 and 24 weeks of TH-substitution The % of decrease of serum thyroid parameters TSH after 1, 2, 4, 6, 12 and 24 weeks of TH-substitution. Consecutive TSH measurements provide an overview of effects on TSH of L-T3 compared to L-T4. It is a measure for TH substitution.
Thyroglobulin (Tg; ng/mL) Before and after 1, 2, 4, 6, 12 and 24 weeks of TH-substitution The % of decrease of serum thyroid parameters TSH and Tg after 1, 2, 4, 6, 12 and 24 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.QoL in patients treated with L-T3 or L-T4 Before and after 2, 6, 12 and 24 weeks of TH-substitution 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).
Heart rate (HR; bpm) Before and after 6 weeks of TH-substitution Cardiovascular parameters will be assessed during visits to the outpatient clinic before initiation of TH-substitution (during hypothyroidism) and after 6 weeks of either L-T3 or L-T4. Patients will be compared intra- and interindividually.
Blood pressure (BP; mmHg) Before and after 6 weeks of TH-substitution Cardiovascular parameters will be assessed during visits to the outpatient clinic before initiation of TH-substitution (during hypothyroidism) and after 6 weeks of either L-T3 or L-T4. Patients will be compared intra- and interindividually.
Lipid profile (cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) Before and after 6 weeks of TH-substitution Cardiovascular parameters will be assessed during visits to the outpatient clinic before initiation of TH-substitution (during hypothyroidism) and after 6 weeks of either L-T3 or L-T4. Patients will be compared intra- and interindividually.
Trial Locations
- Locations (2)
University Medical Center Groningen (UMCG)
🇳🇱Groningen, Netherlands
Radboud University Nijmegen
🇳🇱Nijmegen, Netherlands