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

NCT03024151 — Not applicable, Completed, 150 participants, Inje University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT03024151
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	150 (Actual)
Sponsor	Inje University (Other); collaborators: Dongnam Institute of Radiological & Medical Sciences
Conditions	Thyroid Cancer, Distress, Depression, Anxiety, Fatigue
Interventions	Comthyroid, Synthroid (Drug)
Dates	start 2016-12-01, primary completion 2017-11-01, completion 2017-11-01, first posted 2017-01-18, last updated 2019-02-22
Locations	2 sites in South Korea

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
T4/T3 combination replacement	Active comparator	Drug: Comthyroid	Comthyroid
T4 mono replacement	Active comparator	Drug: Synthroid	Synthroid

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

+Outcome measures

Primary outcomes

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 outcomes

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]

+Eligibility

Sex: All, ages: 20 Years to 70 Years

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

+Locations (2)

Facility	City	Country	Status
Dong sik Bae	Busan	South Korea
Dongsik Bae	Busan	South Korea

My Notes

Public

To Read Reading Read