Thyroid Hormone for Thyroid Cancer

NCT ID: NCT06647602

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-08-31

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

Conditions

Differentiated Thyroid Cancer; Thyroid Cancer; Levothyroxine; Liothyronine; Thyroid Hormones

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Liothyronine cohort

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

Cytomel (liothyronine)

Intervention Type: DRUG

Cytomel (liothyronine sodium tablets; L-T3) is a thyromimetic synthetic drug identical to T3. The pharmacoequivalent ratio of L-T3 to L-T4 is 1:3. The L-T4-cohort receive doses of 2 μg × kg body weight / day. The pharmacoequivalent L-T3 dose would be 1/3th of that namely: 0.67 μg × kg body weight / day. Cytomel will be given trice daily and available dosages are 5, 12.5 and 25 μg.

Levothyroxine cohort

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

Euthyrox (levothyroxine)

Intervention Type: 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.

Interventions

Euthyrox (levothyroxine)

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.

Intervention Type: DRUG

Cytomel (liothyronine)

Cytomel (liothyronine sodium tablets; L-T3) is a thyromimetic synthetic drug identical to T3. The pharmacoequivalent ratio of L-T3 to L-T4 is 1:3. The L-T4-cohort receive doses of 2 μg × kg body weight / day. The pharmacoequivalent L-T3 dose would be 1/3th of that namely: 0.67 μg × kg body weight / day. Cytomel will be given trice daily and available dosages are 5, 12.5 and 25 μg.

Intervention Type: DRUG

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 (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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wouter Zandee, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

University Medical Center Groningen (UMCG)

Groningen, Provincie Groningen, Netherlands

Radboud University Nijmegen

Nijmegen, , Netherlands

Countries

Netherlands

Central Contacts

Mirthe Links, BSc

Role: CONTACT

m.h.links@umcg.nl

+31 50 3610973

Wouter Zandee, MD/PhD

Role: CONTACT

w.t.zandee@umcg.nl

+31 50 3613731

Facility Contacts

Mirthe Links, Bsc

Role: primary

m.h.links@umcg.nl

+31 50 3610973

Mirthe Links, Bsc

Role: primary

m.h.links@umcg.nl

+31 50 3610973

Other Identifiers

NL84560.042.23

Identifier Type: -

Identifier Source: org_study_id