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| Name | Class |
|---|---|
| Dongnam Institute of Radiological & Medical Sciences | OTHER |
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The goal of this research is to compare the effects on psychological distress between T4 mono replacement group and T4/T3 combination replacement group after total thyroidectomy in thyroid cancer patients.
Subjects:
Randomization:
Evaluation for distress:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T4/T3 combination replacement | Active Comparator | Comthyroid |
|
| T4 mono replacement | Active Comparator | Synthroid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comthyroid | Drug | T4/T3 combination replacement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological distress (depression or anxiety) assessed with HADS | Change from baseline HADS total score at 24 weeks | baseline, 24 weeks |
| Fatigue assessed with MDASI-F | Change from baseline MDASI-F score at 24 weeks | baseline, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Depression assessed with BDI | Change from baseline BDI total score at 24 weeks | baseline, 4, 12, 24 weeks |
| Anxiety assessed with BAI | Change from baseline BAI total score at 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong sik Bae | Busan | South Korea | ||||
| Dongsik Bae |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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| Synthroid |
| Drug |
T4 mono replacement |
|
| baseline, 4, 12, 24 weeks |
| Fatigue assessed with BFI | Change from baseline BFI total score at 24 weeks | baseline, 4, 12, 24 weeks |
| Response rate using BDI | improvement of depression sx. ≥ 50% | baseline, 4, 12, 24 weeks |
| Response rate using BAI | improvement of anxiety sx. ≥ 50% | baseline, 4, 12, 24 weeks |
| Response rate using BFI | improvement of fatigue sx. ≥ 50% | baseline, 4, 12, 24 weeks |
| Remisssion rate using BDI | baseline, 4, 12, 24 weeks |
| Remission rate using BAI | baseline, 4, 12, 24 weeks |
| Remission rate using BFI | baseline, 4, 12, 24 weeks |
| Busan |
| South Korea |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |