NCT03024151

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. 1.Subjects:
  2. 2.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.
  3. 3.Randomization:
  4. 4.Using the table of random sampling numbers, patients assign to T4 mono replacement group or T4/T3 combination replacement group.
  5. 5.Evaluation for distress:
  6. 6.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

January 10, 2017

Last Update Submit

February 20, 2019

Conditions

Thyroid CancerDistressDepressionAnxietyFatigue

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Depression assessed with BDI

    baseline, 4, 12, 24 weeks

  • Anxiety assessed with BAI

    baseline, 4, 12, 24 weeks

  • Fatigue assessed with BFI

    baseline, 4, 12, 24 weeks

  • Response rate using BDI

    baseline, 4, 12, 24 weeks

  • Response rate using BAI

    baseline, 4, 12, 24 weeks

  • +4 more secondary outcomes

Study Arms (2)

T4/T3 combination replacement

ACTIVE COMPARATOR

Comthyroid

Drug: Comthyroid

T4 mono replacement

ACTIVE COMPARATOR

Synthroid

Drug: Synthroid

Interventions

ComthyroidDRUG

T4/T3 combination replacement

T4/T3 combination replacement
SynthroidDRUG

T4 mono replacement

T4 mono replacement

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dong sik Bae

Busan, South Korea

Location

Dongsik Bae

Busan, South Korea

Location

MeSH Terms

Conditions

Thyroid NeoplasmsDepressionAnxiety DisordersFatigue

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesBehavioral SymptomsBehaviorMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 18, 2017

Study Start

December 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations

KR(2)