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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03024151
Other study ID # 2016-05-010-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date November 2017

Study information

Verified date February 2019
Source Inje University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

1. Patient who need thyroid hormone replacement therapy after total thyroidectomy for thyroid cancer

2. HADS (Hospital Anxiety and Depression Scale) = 8 for depression or anxiety, or MDASI-F (MD Anderson Symptom Inventory -Fatigue) = 4

3. Patient who maintain TSH recommendation range for TSH suppression according to ATA guidelines

Exclusion Criteria:

1. < 19 or = 70 years old

2. Communication difficulties or inability to complete the necessary investigations and questionnaires

3. Inability to understand purpose of the study or disagree of participation

4. Past history of psychiatric treatment or diagnosis

5. Lactation or pregnancy

6. Past medical history of other cancer diagnosis or treatment

7. Any of severe comorbid medical conditions according to ASA score = 3

Study Design


Intervention

Drug:
Comthyroid
T4/T3 combination replacement
Synthroid
T4 mono replacement

Locations

Country Name City State
Korea, Republic of Dong sik Bae Busan
Korea, Republic of Dongsik Bae Busan

Sponsors (2)

Lead Sponsor Collaborator
Inje University Dongnam Institute of Radiological & Medical Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Psychological distress (depression or anxiety) assessed with HADS Change from baseline HADS total score at 24 weeks baseline, 24 weeks
Primary Fatigue assessed with MDASI-F Change from baseline MDASI-F score at 24 weeks baseline, 24 weeks
Secondary Depression assessed with BDI Change from baseline BDI total score at 24 weeks baseline, 4, 12, 24 weeks
Secondary Anxiety assessed with BAI Change from baseline BAI total score at 24 weeks baseline, 4, 12, 24 weeks
Secondary Fatigue assessed with BFI Change from baseline BFI total score at 24 weeks baseline, 4, 12, 24 weeks
Secondary Response rate using BDI improvement of depression sx. = 50% baseline, 4, 12, 24 weeks
Secondary Response rate using BAI improvement of anxiety sx. = 50% baseline, 4, 12, 24 weeks
Secondary Response rate using BFI improvement of fatigue sx. = 50% baseline, 4, 12, 24 weeks
Secondary Remisssion rate using BDI baseline, 4, 12, 24 weeks
Secondary Remission rate using BAI baseline, 4, 12, 24 weeks
Secondary Remission rate using BFI baseline, 4, 12, 24 weeks
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