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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | December 13, 2021 |
| Main results expected | September 30, 2029 |
| Study ends | September 30, 2029 |
| Registry record updated | December 6, 2023 |
| Trial ID | NCT05316922 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
- Study coordinator: Maura Massimino, MD
- Email: maura.massimino@istitutotumori.mi.it
- Phone: +0390223902593
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
High BMI and periodontitis in Thai adults under 60
This study tests how common high BMI and periodontitis are among Thai adults aged 18–59 and what factors are linked to them.
-
North Star desiccated porcine thyroid tablets for primary hypothyroidism
This phase 3, open-label study tests whether North Star desiccated porcine thyroid tablets can help people with primary hypothyroidism who are already taking a stable dose of LT4.
-
Can a smart wristband help guide levothyroxine dosing after total thyroidectomy
This study tests whether nighttime heart rate and rhythm data from a wearable can hint if levothyroxine dose is too high or too low before the usual blood tests.
-
Internal organ and muscle health in hypothyroidism
This study tests how hypothyroidism affects organ size and muscle strength in adults receiving routine care in Andijan, Uzbekistan.
-
Recovery of hypothyroidism caused by immune checkpoint inhibitors after stopping treatment
This trial will test whether adults who developed hypothyroidism while on immune checkpoint inhibitors can stop levothyroxine after those cancer drugs are stopped.
-
Evaluating diagnostic and therapeutic strategies for thyroid conditions
This study is testing different ways to diagnose and treat thyroid problems, like hypothyroidism and thyroid cancer, to see which methods work best for patients.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.