TSH Suppression During Radiotherapy on Thyroid Site to Prevent Iatrogenic Hypothyroidism in Pediatric Cancer Patients

Last updated: December 5, 2023
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Overall Status: Active - Recruiting

Phase

3

Condition

Female Hormonal Deficiencies/abnormalities

Thyroid Disease

Hormone Deficiencies

Treatment

Levothyroxine

Clinical Study ID

NCT05316922
INT122/21
  • All Genders

Study Summary

To offer the possibility of a treatment that could achieve a meaningful reduction in the incidence of post-radiation therapy hypothyroidism. Thyroid dysfunction may develop from a few months to several years after patients have completed their radiation treatment. In children with chronic diseases, or given lengthy anti-neoplastic treatments, recurrent or persistent endocrine disorders may have a negative effect on growth and development into adulthood.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma before radiotherapy (RT) planning including thyroid parenchyma without previous primary or secondaryhypothyroidism;
  2. Written informed consent prior to any study-specific analysis and/or data collection.

Exclusion

Exclusion Criteria:

  1. Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma after radiotherapyincluding thyroid parenchyma;
  2. Not signed consent.

Study Design

Total Participants: 68
Treatment Group(s): 1
Primary Treatment: Levothyroxine
Phase: 3
Study Start date:
December 13, 2021
Estimated Completion Date:
September 30, 2029

Study Description

Patients will undergo basal thyroid ultrasound and FT3, FT4, TSH assay. Simulations with computed tomography, and computer assisted three-dimensional treatment planning with a dose volume histogram will be used to identify thyroid volumes and corresponding RT isodose distributions.

The enrolled patients will be randomly assigned (1:1) to TSH suppression group (experimental group) or non-TSH suppression group (control group). Random allocation will be managed centrally by Clinical epidemiology and Trial organization of the Fondazione IRCCS Istituto Nazionale dei Tumori. The randomization list will be generated by SAS software. Investigators and patients will not be masked to treatment allocation.

From 14 days beforehand and throughout their RT, patients in the experimental arm will receive L-thyroxine in the morning on an empty stomach (half an hour before breakfast), starting with 1-2 μg/kg, and adjusting the dose every 3 days to ensure TSH < 0.3 μIU/mL before RT beginning. The 0.3 μIU/mL threshold is just below normal range not causing hyperthyroidism, and is defined as "mild" TSH suppression. Based on hormone status, L-thyroxine doses will be gradually increased to patients' individual minimum TSH-suppressive dose before starting RT, maintained throughout the treatment, then rapidly tapered off (half dose the next day after RT, 25% the following day and stop).

Connect with a study center

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.