TerminatedPhase 4

Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy

Stopped: Terminating study as sponsor has sold the drug to another company

United States14 participantsStarted 2017-02-01

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Patients in Each Group at Predefined Target TSH Range at 18 Weeks

Timeframe: 18 weeks

Trial details

NCT IDNCT02946918

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-04

Results submitted2020-11-04

View on ClinicalTrials.gov More Thyroid Cancer trials