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NCT03024151
The Effects of T4 Mono Replacement Versus T4/T3 Combination Replacement on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients; Prospective, Randomized, Double Blind, T4 Comparative Clinical Study
NA trial testing Comthyroid in Thyroid Cancer in 150 participants. Completed in 1 November 2017.
1 November 2017
Quick facts
| Lead sponsor | Inje University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 1 December 2016 |
| Primary completion | 1 November 2017 |
| Estimated completion | 1 November 2017 |
| Sites | 2 locations across South Korea |
Drugs / interventions tested
- Comthyroid — full drug profile →
- Synthroid — full drug profile →
Conditions studied
- Thyroid Cancer — all drugs for Thyroid Cancer →
- Distress — all drugs for Distress →
- Depression — all drugs for Depression →
- Anxiety — all drugs for Anxiety →
Sponsor
Inje University
Who can join
Adults 20 to 70, any sex, with Thyroid Cancer or Distress. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Psychological distress (depression or anxiety) assessed with HADS
Time frame: baseline, 24 weeks
Change from baseline HADS total score at 24 weeks -
Fatigue assessed with MDASI-F
Time frame: baseline, 24 weeks
Change from baseline MDASI-F score at 24 weeks
Sponsor's own description
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. 1. Subjects: * Psychologically distressed patients, such as depression, anxiety, and fatigue patient after total thyroidectomy with thyroid cancer are considered for participation. Screening of distress after total thyroidectomy is used HADS (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, and MDASI-F (MD Anderson Symptom Inventory -Fatigue) ≥ 4 for fatigue. 2. Randomization: * Using the table of random sampling numbers, patients assign to T4 mono replacement group or T4/T3 combination replacement group. 3. Evaluation for distress: * Assessment will be made baseline, 4 weeks, 12 weeks and 24 weeks to investigate change of psychological distress (depression, anxiety, and fatigue). Level of distress after thyroidectomy will determine using Hospital Anxiety and Depression Scale (HADS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) for depression or anxiety, and Brief Fatigue Inventory (BFI) for fatigue.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03024151
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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- NCT07419932 — Response to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer · recruiting
Other Inje University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03024151 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Inje University
- Last refreshed: 20 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03024151.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing