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SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Department of Internal Medicine, Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Contact Information
Primary
Min Joo Kim, Professor
mjkim@snubh.org
+82-31-787-7855
Time Frame
Start Date: 2024-06-12
Estimated Completion Date: 2029-03-04
Participants
Target number of participants: 107
Treatments
Experimental: Levothyroxine tapering arm
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.
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Bundang Hospital

This content was sourced from clinicaltrials.gov