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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Fatigue; Anxiety; Distress; Thyroid Cancer
• Intervention / Treatment: Drug: Comthyroid; Drug: Synthroid

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Dong sik Bae
  • Busan, Korea, Republic of
    • Dongsik Bae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: T4/T3 combination replacement; Comthyroid	Drug: Comthyroid; T4/T3 combination replacement
Active Comparator: T4 mono replacement; Synthroid	Drug: Synthroid; T4 mono replacement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Inje University
• Collaborators: Dongnam Institute of Radiological & Medical Sciences

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 15, 2017
• First Posted (Estimate): January 18, 2017

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: 2016-05-010-001