Preventing thyroid problems in children undergoing radiation therapy for cancer
Protection From Iatrogenic Hypothyroidism Patients With MBL and Pediatric Patients With HL and Non-HL Needing Radiotherapy on Thyroid Site
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 |
| Enrollment | 68 (estimated) |
| Sex | All |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milan) |
| Trial ID | NCT05316922 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children diagnosed with medulloblastoma or Hodgkin/non-Hodgkin lymphoma who are about to undergo radiation therapy.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Maura Massimino, MD
- Email: maura.massimino@istitutotumori.mi.it
- Phone: +0390223902593
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.