Thyroid CancerPhase 4NCT02946918
Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy
A Phase 4 study testing Levothyroxine in people with Thyroid Cancer and Postsurgical Hypothyroidism, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
In some patients, levothyroxine liquid gel capsules may demonstrate superior absorption than the tablet option. Impaired absorption of thyroid hormone directly correlates to higher and more unpredictable TSH (thyroid stimulating hormone) levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Postsurgical Hypothyroidism
- What is being tested?
- Levothyroxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 4 Nov 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Presumed AJCC (American Joint Committee on Cancer) tumor Stage I or II
- Planned total or near-total thyroidectomy
- Planned goal TSH suppression 0.1-0.5 mU/L for at least 18 weeks postoperatively
- Normal serum TSH within 12 months preceding surgery
Who cannot join
- AJCC Stage III or greater
- Undifferentiated, Anaplastic or Medullary Thyroid Cancer
- Planned postoperative TSH goal other than 0.1-0.5 mU/L
- History of gastrointestinal malabsorption or gastric bypass surgery
- Pregnancy
- Use of medications that alter the absorption or metabolism of levothyroxine
- Prior use of levothyroxine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Levothyroxine Replacement With Liquid Gel Capsules or Tablets in Post-thyroidectomy Stage in Low Risk Differentiated Thyroid Cancer Patients
In some patients, levothyroxine liquid gel capsules may demonstrate superior absorption than the tablet option. Impaired absorption of thyroid hormone directly correlates to higher and more unpredictable TSH (thyroid stimulating hormone) levels.
The investigators therefore hypothesize that following thyroidectomy for Stage I/II differentiated thyroid cancer the gel capsule levothyroxine formulation will provide more predictable TSH results and in turn require fewer dose adjustments to achieve optimal hormone levels in the postoperative period.
The aim of this investigation is to compare the use of levothyroxine in liquid gel capsules to tablet form for TSH suppression following thyroidectomy for presumed stage I/II differentiated thyroid cancer.
Read the detailed description
Ten patients will be randomized prior to surgery to receive levothyroxine in tablet form and ten patients will be randomized to receive in gel capsule form. Both forms will be encapsulated in order to allow double-blinding of the study.
The postoperative goal TSH will be between 0.1 and 0.5 mU/L (milli units per litre) in both arms.
Patients will be seen at weeks 6, 12 and 18 postoperatively and have TSH and Free T4 measured. The primary outcome is the number of patients at each visit that are at goal range TSH.
A secondary analysis will compare the dose changes required between the two groups in order to achieve goal TSH.
Another secondary analysis will investigate the patients' quality of life. Two different surveys (see secondary outcomes below) will be performed at both study entry and completion to compare the two groups.
- Conditions
- Thyroid Cancer, Postsurgical Hypothyroidism
- Being tested
- Levothyroxine
- Keywords
- levothyroxine
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxineDrug
Also called Tirosint, Synthroid
Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps. Initial dose 1.5-1.8 mcg per kg, orally and daily
| Study group | Role | What they receive |
|---|---|---|
| Tablets | Experimental | Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes) Receives: Drug: Levothyroxine |
| Gelcaps | Experimental | Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes) Receives: Drug: Levothyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients in Each Group at Predefined Target TSH Range at 18 Weeks
The target TSH (Thyroid stimulating hormone) range will be 0.1 to 0.5 mU/L. The number of patients in each arm (gelcaps or tablets) who are in this range at the completion of the study (18 weeks) will be assessed and the data compared at completion of the study.
Measured: 18 weeks
Secondary outcomes (3)
Mean Number of Dose Adjustments
The number of dose adjustments required to attain TSH target range for each formulation will be tabulated and the data compared at the end of the study
Measured: 18 weeks
Change in Mean Patient Quality of Life Score
Patients will be administered survey (Thyroid-Dependent Quality of Life ) to assess their quality of life (at the beginning of the study and again at study completion). The results of these scores will be tabulated and compared between the two arms. Possible score range from 0 to 450; lower score means improved quality of life.
Measured: Baseline,18 weeks
Treatment Satisfaction Survey
The Thyroid Treatment Satisfaction Questionnaire Measures the treatment satisfaction. Possible measure 0 to 42; Higher the score, better the outcome (more satisfied the patient)
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start1 Feb 2017
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
Why it stopped: Terminating study as sponsor has sold the drug to another company
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Akrimax Pharmaceuticals
- Responsible party
- Principal investigator, Alex Tessnow, University of Texas Southwestern Medical Center
- Investigators
- Alex Tessnow, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946918
- Sponsor's protocol ID
- STU 022015-044
- Status last verified
- Nov 2020
- First submitted
- 21 Oct 2016
- Last updated
- 1 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vita R, Fallahi P, Antonelli A, Benvenga S. The administration of L-thyroxine as soft gel capsule or liquid solution. Expert Opin Drug Deliv. 2014 Jul;11(7):1103-11. doi: 10.1517/17425247.2014.918101. Epub 2014 Jun 4.
PubMed 24896369McMillan CV, Bradley C, Woodcock A, Razvi S, Weaver JU. Design of new questionnaires to measure quality of life and treatment satisfaction in hypothyroidism. Thyroid. 2004 Nov;14(11):916-25. doi: 10.1089/thy.2004.14.916.
PubMed 15671770
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levothyroxine Replacement With Liquid Gel Capsules or Tablets in Post-thyroidectomy Stage in Low Risk Differentiated Thyroid Cancer Patients
- ClinicalTrials.gov ID
- NCT02946918
- Acronym / sponsor ID
- STU 022015-044
- Conditions
- Thyroid Cancer, Postsurgical Hypothyroidism
- Keywords
- levothyroxine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminating study as sponsor has sold the drug to another company
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Akrimax Pharmaceuticals
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Posted 1 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In some patients, levothyroxine liquid gel capsules may demonstrate superior absorption than the tablet option. Impaired absorption of thyroid hormone directly correlates to higher and more unpredictable TSH (thyroid stimulating hormone) levels.
The investigators therefore hypothesize that following thyroidectomy for Stage I/II differentiated thyroid cancer the gel capsule levothyroxine formulation will provide more predictable TSH results and in turn require fewer dose adjustments to achieve optimal hormone levels in the postoperative period.
The aim of this investigation is to compare the use of levothyroxine in liquid gel capsules to tablet form for TSH suppression following thyroidectomy for presumed stage I/II differentiated thyroid cancer.
Detailed description
Ten patients will be randomized prior to surgery to receive levothyroxine in tablet form and ten patients will be randomized to receive in gel capsule form. Both forms will be encapsulated in order to allow double-blinding of the study.
The postoperative goal TSH will be between 0.1 and 0.5 mU/L (milli units per litre) in both arms.
Patients will be seen at weeks 6, 12 and 18 postoperatively and have TSH and Free T4 measured. The primary outcome is the number of patients at each visit that are at goal range TSH.
A secondary analysis will compare the dose changes required between the two groups in order to achieve goal TSH.
Another secondary analysis will investigate the patients' quality of life. Two different surveys (see secondary outcomes below) will be performed at both study entry and completion to compare the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablets | Experimental | Drug: LevothyroxinePatients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes) |
| Gelcaps | Experimental | Drug: LevothyroxinePatients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Presumed AJCC (American Joint Committee on Cancer) tumor Stage I or II
- Planned total or near-total thyroidectomy
- Planned goal TSH suppression 0.1-0.5 mU/L for at least 18 weeks postoperatively
- Normal serum TSH within 12 months preceding surgery
Key exclusion criteria (7 listed)
- AJCC Stage III or greater
- Undifferentiated, Anaplastic or Medullary Thyroid Cancer
- Planned postoperative TSH goal other than 0.1-0.5 mU/L
- History of gastrointestinal malabsorption or gastric bypass surgery
- 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 |
|---|---|---|
| LevothyroxineAlso: Tirosint, SynthroidPatients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps. Initial dose 1.5-1.8 mcg per kg, orally and daily | Drug | Gelcaps, Tablets |
Primary outcome
Number of Patients in Each Group at Predefined Target TSH Range at 18 Weeks
Time frame: 18 weeks
The target TSH (Thyroid stimulating hormone) range will be 0.1 to 0.5 mU/L. The number of patients in each arm (gelcaps or tablets) who are in this range at the completion of the study (18 weeks) will be assessed and the data compared at completion of the study.
3 secondary outcomes
Mean Number of Dose Adjustments
Time frame: 18 weeks
Change in Mean Patient Quality of Life Score
Time frame: Baseline,18 weeks
Treatment Satisfaction Survey
Time frame: 18 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24896369Vita R, Fallahi P, Antonelli A, Benvenga S. The administration of L-thyroxine as soft gel capsule or liquid solution. Expert Opin Drug Deliv. 2014 Jul;11(7):1103-11. doi: 10.1517/17425247.2014.918101. Epub 2014 Jun 4.
- Background: PubMed 15671770McMillan CV, Bradley C, Woodcock A, Razvi S, Weaver JU. Design of new questionnaires to measure quality of life and treatment satisfaction in hypothyroidism. Thyroid. 2004 Nov;14(11):916-25. doi: 10.1089/thy.2004.14.916.
- Individual participant dataSharing planned: No
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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.
Alex Tessnow, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levothyroxine in people with Thyroid Cancer and Postsurgical Hypothyroidism, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients in Each Group at Predefined Target TSH Range at 18 Weeks (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02946918, which also lists 2 linked publications.
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 1 Dec 2020.