The Effects of T4 Versus T4/T3 on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03024151
• Other study ID #: 2016-05-010-001
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Distress
• Fatigue
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

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