SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery Trial
Seoul National University Bundang Hospital
107 participants
Jun 12, 2024
INTERVENTIONAL
Conditions
Summary
The goal of this study is to find out whether hypothyroidism caused by immune checkpoint inhibitors (ICIs) can recover after stopping the ICIs. The study also aims to identify factors that can help predict which patients will be able to stop taking thyroid hormone replacement. The main questions the study will answer are: * What percentage of patients recover normal thyroid function and can stop levothyroxine after stopping ICIs? * What clinical or laboratory factors can predict successful withdrawal of levothyroxine? Participants will: * Be adult cancer patients who developed hypothyroidism during ICI treatment and are currently taking levothyroxine * Have already stopped ICI therapy * Gradually reduce their levothyroxine dose every 3 months if their thyroid function remains normal * Stop levothyroxine if thyroid function remains normal at low doses (≤0.025 mg) * Be monitored with thyroid function tests and clinical symptoms at each visit
Eligibility
Inclusion Criteria4
- Adults aged 19 years or older.
- Patients with a history of treatment with immune checkpoint inhibitors (ICIs).
- Developed hypothyroidism during ICI treatment and initiated levothyroxine after starting ICI therapy.
- Discontinued ICI therapy prior to study enrollment.
Exclusion Criteria3
- Use of levothyroxine or antithyroid medications within 3 months prior to initiating ICI therapy.
- History of thyroid surgery, radioactive iodine therapy, or neck radiation therapy.
- Current levothyroxine dose ≥0.1 mg at the time of enrollment.
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Interventions
Participants will undergo a gradual dose reduction of levothyroxine according to a standardized tapering protocol. The levothyroxine dose will be reduced every 3 months based on thyroid function test results. If thyroid function remains stable, the dose will be decreased by 0.025 mg (±0.0125 mg). If thyroid function remains stable at a low dose (≤0.025 mg), levothyroxine will be discontinued.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07421869