Thyroid CancerNCT03024151
The Effects of T4 Versus T4/T3 on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients
A study testing Comthyroid and Synthroid in people with Thyroid Cancer and Distress, run by Inje University at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Thyroid Cancer, Distress, Depression
- What is being tested?
- Comthyroid and Synthroid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Dec 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 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
Trial locations and contacts
2 sites in 1 country.
About this study
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
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:
Read more
- 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.
- Conditions
- Thyroid Cancer, Distress, Depression, Anxiety, Fatigue
- Being tested
- Comthyroid, Synthroid
- Medical subject headings
- Thyroid Neoplasms, Depression, Anxiety Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComthyroidDrug
T4/T3 combination replacement
SynthroidDrug
T4 mono replacement
| Study group | Role | What they receive |
|---|---|---|
| T4/T3 combination replacement | Active comparator | Comthyroid Receives: Drug: Comthyroid |
| T4 mono replacement | Active comparator | Synthroid Receives: Drug: Synthroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological distress (depression or anxiety) assessed with HADS
Change from baseline HADS total score at 24 weeks
Measured: baseline, 24 weeks
Fatigue assessed with MDASI-F
Change from baseline MDASI-F score at 24 weeks
Measured: baseline, 24 weeks
Secondary outcomes (9)
Depression assessed with BDI
Change from baseline BDI total score at 24 weeks
Measured: baseline, 4, 12, 24 weeks
Anxiety assessed with BAI
Change from baseline BAI total score at 24 weeks
Measured: baseline, 4, 12, 24 weeks
Fatigue assessed with BFI
Change from baseline BFI total score at 24 weeks
Measured: baseline, 4, 12, 24 weeks
Response rate using BDI
improvement of depression sx. ≥ 50%
Measured: baseline, 4, 12, 24 weeks
Response rate using BAI
improvement of anxiety sx. ≥ 50%
Measured: baseline, 4, 12, 24 weeks
Response rate using BFI
improvement of fatigue sx. ≥ 50%
Measured: baseline, 4, 12, 24 weeks
Remisssion rate using BDI
Measured: baseline, 4, 12, 24 weeks
Remission rate using BAI
Measured: baseline, 4, 12, 24 weeks
Remission rate using BFI
Measured: baseline, 4, 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Collaborators
- Dongnam Institute of Radiological & Medical Sciences
- Responsible party
- Principal investigator, Dongsik Bae, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024151
- Sponsor's protocol ID
- 2016-05-010-001
- Status last verified
- Feb 2019
- First submitted
- 10 Jan 2017
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03024151
- Acronym / sponsor ID
- 2016-05-010-001
- Conditions
- Thyroid Cancer, Distress, Depression, Anxiety, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Collaborators
- Dongnam Institute of Radiological & Medical Sciences
- Study start
- Dec 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T4/T3 combination replacement | Active comparator | Drug: ComthyroidComthyroid |
| T4 mono replacement | Active comparator | Drug: SynthroidSynthroid |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ComthyroidT4/T3 combination replacement | Drug | T4/T3 combination replacement |
| SynthroidT4 mono replacement | Drug | T4 mono replacement |
Primary outcome
Psychological distress (depression or anxiety) assessed with HADS
Time frame: baseline, 24 weeks
Change from baseline HADS total score at 24 weeks
Fatigue assessed with MDASI-F
Time frame: baseline, 24 weeks
Change from baseline MDASI-F score at 24 weeks
9 secondary outcomes
Depression assessed with BDI
Time frame: baseline, 4, 12, 24 weeks
Anxiety assessed with BAI
Time frame: baseline, 4, 12, 24 weeks
Fatigue assessed with BFI
Time frame: baseline, 4, 12, 24 weeks
Response rate using BDI
Time frame: baseline, 4, 12, 24 weeks
Response rate using BAI
Time frame: baseline, 4, 12, 24 weeks
Response rate using BFI
Time frame: baseline, 4, 12, 24 weeks
Remisssion rate using BDI
Time frame: baseline, 4, 12, 24 weeks
Remission rate using BAI
Time frame: baseline, 4, 12, 24 weeks
Remission rate using BFI
Time frame: baseline, 4, 12, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
Related trials for Thyroid Cancer
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Recruiting
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Thyroid Gland Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comthyroid and Synthroid in people with Thyroid Cancer and Distress, run by Inje University at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress (depression or anxiety) assessed with HADS (time frame: baseline, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.