RecruitingPhase 3NCT05316922

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

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

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Enrollment

68 participants

Start Date

Dec 13, 2021

Study Type

INTERVENTIONAL

Conditions

Hypothyroidism; Irradiation

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

Plain Language Summary

Simplified for easier understanding

This study tests whether temporarily suppressing TSH (a hormone that stimulates the thyroid) during radiation therapy can protect the thyroid gland in children receiving radiation for brain or lymph node cancers. Radiation to the neck area can damage the thyroid and cause hypothyroidism (an underactive thyroid) as a long-term side effect. **You may be eligible if...** - You are a child or adolescent about to start radiation therapy for medulloblastoma (a brain tumor) or Hodgkin/non-Hodgkin lymphoma, where the radiation field includes the thyroid gland - You do not have pre-existing primary or secondary hypothyroidism - You have signed informed consent **You may NOT be eligible if...** - You have already completed the radiation therapy course - You refused to sign informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLevothyroxine

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.

Locations(1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

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NCT05316922