Trial | NCT03024151  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    150
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.

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.

Randomization:

Using the table of random sampling numbers, patients assign to T4 mono replacement group or T4/T3 combination replacement group.

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 Started
Dec 31
2016
Primary Completion
Nov 30
2017
Study Completion
Nov 30
2017
Last Update
Feb 22
2019

Drug Comthyroid

T4/T3 combination replacement

Drug Synthroid

T4 mono replacement

T4/T3 combination replacement Active Comparator

Comthyroid

T4 mono replacement Active Comparator

Synthroid

Criteria 

Inclusion Criteria:

Patient who need thyroid hormone replacement therapy after total thyroidectomy for thyroid cancer
HADS (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, or MDASI-F (MD Anderson Symptom Inventory -Fatigue) ≥ 4
Patient who maintain TSH recommendation range for TSH suppression according to ATA guidelines

Exclusion Criteria:

< 19 or ≥ 70 years old
Communication difficulties or inability to complete the necessary investigations and questionnaires
Inability to understand purpose of the study or disagree of participation
Past history of psychiatric treatment or diagnosis
Lactation or pregnancy
Past medical history of other cancer diagnosis or treatment
Any of severe comorbid medical conditions according to ASA score ≥ 3
No Results Posted