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Clinical Trials in Italy / NCT05316922
Recruiting Phase 3

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

NCT05316922 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Phase
Phase 3
Started
2021-12-13
Last updated
2023-12-06

Condition(s) studied

Hypothyroidism; Irradiation

Investigational drug(s) / intervention(s)

Levothyroxine →

Levothyroxine: Levothyroxine is used to treat hypothyroidism (low thyroid function). This medicine is given when your thyroid does not produce enough of this hormone on its own.

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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma before radiotherapy (RT) planning including thyroid parenchyma without previous primary or secondary hypothyroidism; 2. Written informed consent prior to any study-specific analysis and/or data collection. Exclusion Criteria: 1. Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma after radiotherapy including thyroid parenchyma; 2. Not signed consent.

Primary outcome measure(s)

  • Hypothyroidism-free survival — 3 years
    Hypothyroidism-free survival at 3 years after radiotherapy including part or the whole thyroid parenchyma on the intention-to-treat population will be the main end-point.

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy Recruiting

On this site

📄 Synthroid (levothyroxine) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05316922 on ClinicalTrials.gov ↗ ← All trials in Italy