Thyroid Hormone for Thyroid Cancer (T4T)

University Medical Center Groningen (UMCG)

Status: Not yet enrolling

Conditions: Liothyronine; Levothyroxine; Thyroid Hormones; Differentiated Thyroid Cancer; Thyroid Cancer

Treatments: Drug: Euthyrox (levothyroxine); Drug: Cytomel (liothyronine)

Study type: Observational

Funder types: Other

Identifiers

NCT06647602

NL84560.042.23

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

40 participants in 2 patient groups

Liothyronine cohort

Description:

Patients in the UMCG will receive L-T3 according to local protocol.

Treatment:

Drug: Cytomel (liothyronine)

Levothyroxine cohort

Description:

Patients in the Radboud UMC will receive L-T4 according to local protocol.

Treatment:

Drug: Euthyrox (levothyroxine)