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

Not Applicable

Completed

• Conditions: Depression; Anxiety; Fatigue; Distress; Thyroid Cancer
• Interventions: Drug: Comthyroid; Drug: Synthroid

• Registration Number: NCT03024151
• Lead Sponsor: Inje University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-15
• Study First Posted: 2017-01-18
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T4/T3 combination replacement	Comthyroid	Comthyroid
T4 mono replacement	Synthroid	Synthroid

Primary Outcome Measures

Name	Time	Method
Psychological distress (depression or anxiety) assessed with HADS	baseline, 24 weeks	Change from baseline HADS total score at 24 weeks
Fatigue assessed with MDASI-F	baseline, 24 weeks	Change from baseline MDASI-F score at 24 weeks

Secondary Outcome Measures

Name	Time	Method
Depression assessed with BDI	baseline, 4, 12, 24 weeks	Change from baseline BDI total score at 24 weeks
Anxiety assessed with BAI	baseline, 4, 12, 24 weeks	Change from baseline BAI total score at 24 weeks
Fatigue assessed with BFI	baseline, 4, 12, 24 weeks	Change from baseline BFI total score at 24 weeks
Response rate using BDI	baseline, 4, 12, 24 weeks	improvement of depression sx. ≥ 50%
Response rate using BAI	baseline, 4, 12, 24 weeks	improvement of anxiety sx. ≥ 50%
Response rate using BFI	baseline, 4, 12, 24 weeks	improvement of fatigue sx. ≥ 50%
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

Trial Locations

Locations (2)

Dongsik Bae; 🇰🇷 Busan, Korea, Republic of

Dong sik Bae; 🇰🇷 Busan, Korea, Republic of