<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03024151</url>
  </required_header>
  <id_info>
    <org_study_id>2016-05-010-001</org_study_id>
    <nct_id>NCT03024151</nct_id>
  </id_info>
  <brief_title>The Effects of T4 Versus T4/T3 on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients</brief_title>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dongnam Institute of Radiological &amp; Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Inje University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research is to compare the effects on psychological distress between T4 mono&#xD;
      replacement group and T4/T3 combination replacement group after total thyroidectomy in&#xD;
      thyroid cancer patients.&#xD;
&#xD;
        1. Subjects:&#xD;
&#xD;
             -  Psychologically distressed patients, such as depression, anxiety, and fatigue&#xD;
                patient after total thyroidectomy with thyroid cancer are considered for&#xD;
                participation. Screening of distress after total thyroidectomy is used HADS&#xD;
                (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, and MDASI-F&#xD;
                (MD Anderson Symptom Inventory -Fatigue) ≥ 4 for fatigue.&#xD;
&#xD;
        2. Randomization:&#xD;
&#xD;
             -  Using the table of random sampling numbers, patients assign to T4 mono replacement&#xD;
                group or T4/T3 combination replacement group.&#xD;
&#xD;
        3. Evaluation for distress:&#xD;
&#xD;
             -  Assessment will be made baseline, 4 weeks, 12 weeks and 24 weeks to investigate&#xD;
                change of psychological distress (depression, anxiety, and fatigue). Level of&#xD;
                distress after thyroidectomy will determine using Hospital Anxiety and Depression&#xD;
                Scale (HADS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) for&#xD;
                depression or anxiety, and Brief Fatigue Inventory (BFI) for fatigue.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Psychological distress (depression or anxiety) assessed with HADS</measure>
    <time_frame>baseline, 24 weeks</time_frame>
    <description>Change from baseline HADS total score at 24 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue assessed with MDASI-F</measure>
    <time_frame>baseline, 24 weeks</time_frame>
    <description>Change from baseline MDASI-F score at 24 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression assessed with BDI</measure>
    <time_frame>baseline, 4, 12, 24 weeks</time_frame>
    <description>Change from baseline BDI total score at 24 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety assessed with BAI</measure>
    <time_frame>baseline, 4, 12, 24 weeks</time_frame>
    <description>Change from baseline BAI total score at 24 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue assessed with BFI</measure>
    <time_frame>baseline, 4, 12, 24 weeks</time_frame>
    <description>Change from baseline BFI total score at 24 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate using BDI</measure>
    <time_frame>baseline, 4, 12, 24 weeks</time_frame>
    <description>improvement of depression sx. ≥ 50%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate using BAI</measure>
    <time_frame>baseline, 4, 12, 24 weeks</time_frame>
    <description>improvement of anxiety sx. ≥ 50%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate using BFI</measure>
    <time_frame>baseline, 4, 12, 24 weeks</time_frame>
    <description>improvement of fatigue sx. ≥ 50%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remisssion rate using BDI</measure>
    <time_frame>baseline, 4, 12, 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission rate using BAI</measure>
    <time_frame>baseline, 4, 12, 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission rate using BFI</measure>
    <time_frame>baseline, 4, 12, 24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Thyroid Cancer</condition>
  <condition>Distress</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>T4/T3 combination replacement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Comthyroid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>T4 mono replacement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Synthroid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Comthyroid</intervention_name>
    <description>T4/T3 combination replacement</description>
    <arm_group_label>T4/T3 combination replacement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Synthroid</intervention_name>
    <description>T4 mono replacement</description>
    <arm_group_label>T4 mono replacement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient who need thyroid hormone replacement therapy after total thyroidectomy for&#xD;
             thyroid cancer&#xD;
&#xD;
          2. HADS (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, or MDASI-F&#xD;
             (MD Anderson Symptom Inventory -Fatigue) ≥ 4&#xD;
&#xD;
          3. Patient who maintain TSH recommendation range for TSH suppression according to ATA&#xD;
             guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. &lt; 19 or ≥ 70 years old&#xD;
&#xD;
          2. Communication difficulties or inability to complete the necessary investigations and&#xD;
             questionnaires&#xD;
&#xD;
          3. Inability to understand purpose of the study or disagree of participation&#xD;
&#xD;
          4. Past history of psychiatric treatment or diagnosis&#xD;
&#xD;
          5. Lactation or pregnancy&#xD;
&#xD;
          6. Past medical history of other cancer diagnosis or treatment&#xD;
&#xD;
          7. Any of severe comorbid medical conditions according to ASA score ≥ 3&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dong sik Bae</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dongsik Bae</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inje University</investigator_affiliation>
    <investigator_full_name>Dongsik Bae</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03024151
org study id: 2016-05-010-001
nct id: NCT03024151
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Psychological distress (depression or anxiety) assessed with HADS
time frame: baseline, 24 weeks
description: Change from baseline HADS total score at 24 weeks
measure: Fatigue assessed with MDASI-F
time frame: baseline, 24 weeks
description: Change from baseline MDASI-F score at 24 weeks
measure: Depression assessed with BDI
time frame: baseline, 4, 12, 24 weeks
description: Change from baseline BDI total score at 24 weeks
measure: Anxiety assessed with BAI
time frame: baseline, 4, 12, 24 weeks
description: Change from baseline BAI total score at 24 weeks
measure: Fatigue assessed with BFI
time frame: baseline, 4, 12, 24 weeks
description: Change from baseline BFI total score at 24 weeks
measure: Response rate using BDI
time frame: baseline, 4, 12, 24 weeks
description: improvement of depression sx. ≥ 50%
measure: Response rate using BAI
time frame: baseline, 4, 12, 24 weeks
description: improvement of anxiety sx. ≥ 50%
measure: Response rate using BFI
time frame: baseline, 4, 12, 24 weeks
description: improvement of fatigue sx. ≥ 50%
measure: Remisssion rate using BDI
time frame: baseline, 4, 12, 24 weeks
measure: Remission rate using BAI
time frame: baseline, 4, 12, 24 weeks
measure: Remission rate using BFI
time frame: baseline, 4, 12, 24 weeks
arm group label: T4/T3 combination replacement
arm group type: Active Comparator
description: Comthyroid
arm group label: T4 mono replacement
arm group type: Active Comparator
description: Synthroid
intervention type: Drug
intervention name: Comthyroid
description: T4/T3 combination replacement
arm group label: T4/T3 combination replacement
intervention type: Drug
intervention name: Synthroid
description: T4 mono replacement
arm group label: T4 mono replacement
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Inje University
investigator full name: Dongsik Bae
investigator title: Professor
mesh term: Thyroid Neoplasms
mesh term: Thyroid Diseases