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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

Completed NA Last updated 20 February 2019
What this trial tests

NA trial testing Comthyroid in Thyroid Cancer in 150 participants. Completed in 1 November 2017.

Timeline
1 December 2016
Primary endpoint
1 November 2017
1 November 2017

Quick facts

Lead sponsorInje University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment150
Start date1 December 2016
Primary completion1 November 2017
Estimated completion1 November 2017
Sites2 locations across South Korea

Drugs / interventions tested

Conditions studied

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.

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:

Other recruiting trials for Thyroid Cancer

Currently open trials in the same condition.

Other Inje University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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