SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Levothyroxine tapering.
- Who it may be relevant to
- Registry conditions: Hypothyroidism. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Drug Levothyroxine tapering
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.
Primary outcome measures
- Proportion of participants who maintain discontinuation of levothyroxine for at least 6 months [Time frame: Up to 6 months after levothyroxine discontinuation]
Secondary outcome measures (3)
- Proportion of participants who can discontinue levothyroxine [Time frame: up to 3 years after study enrollment]
- Proportion of participants who maintain discontinuation of levothyroxine for at least 12 months [Time frame: Up to 12 months after levothyroxine discontinuation]
- Proportion of participants who maintain discontinuation of levothyroxine for at least 36 months [Time frame: Up to 36 months after levothyroxine discontinuation]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Department of Internal Medicine, Seoul National University Bundang Hospital — Seongnam-si
Identifiers
NCT: NCT07421869 · IRB-B-2401-879-001