Clinical trial Recruiting at 1 site Phase 3 Interventional

Preventing thyroid problems in children undergoing radiation therapy for cancer

Official title: Protection From Iatrogenic Hypothyroidism Patients With MBL and Pediatric Patients With HL and Non-HL Needing Radiotherapy on Thyroid Site

Run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · NCT05316922 · Data updated 2026-11-12

This study is testing if giving a thyroid medication to children with cancer who are getting radiation therapy can help prevent thyroid problems later on.

Quick facts

PhasePhase 3
Study typeInterventional
SexAll
Enrollment68 (estimated)
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano
Academic / other
Drugs / interventionsradiation
Locations1 site (Milan)
StatusRecruiting
StartedDecember 13, 2021
Main results expectedSeptember 30, 2029
Study endsSeptember 30, 2029
Registry record updatedDecember 6, 2023
Trial IDNCT05316922 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children diagnosed with medulloblastoma or Hodgkin/non-Hodgkin lymphoma who are about to undergo radiation therapy.

Probably not a fit

Patients who have already undergone radiation therapy or those who have a history of primary or secondary hypothyroidism will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to reduce the incidence of hypothyroidism in pediatric cancer patients receiving radiation therapy by suppressing thyroid-stimulating hormone (TSH) levels. Participants will be randomly assigned to either a TSH suppression group, receiving L-thyroxine, or a control group without TSH suppression. The study will involve baseline thyroid assessments and careful monitoring of hormone levels throughout the treatment process. The goal is to maintain TSH levels below a specific threshold during radiation therapy to prevent long-term thyroid dysfunction.

Why it matters

Potential benefit: If successful, this approach could significantly decrease the risk of hypothyroidism in children treated for cancer, improving their long-term health outcomes.

How similar studies have gone: While the specific approach of TSH suppression during radiation therapy is novel, similar studies have indicated that hormone management can positively influence outcomes in patients undergoing cancer treatment.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Fondazione IRCCS Istituto Nazionale dei Tumori
    Milan, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.