Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy

November 4, 2020 updated by: Alex Tessnow, University of Texas Southwestern Medical Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tablets
Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)
Drug: Levothyroxine
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
Other Names:
  • Tirosint, Synthroid
EXPERIMENTAL: Gelcaps
Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)
Drug: Levothyroxine
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
Other Names:
  • Tirosint, Synthroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Number of Dose Adjustments
Time Frame: 18 weeks
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
18 weeks
Change in Mean Patient Quality of Life Score
Time Frame: Baseline,18 weeks
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.
Baseline,18 weeks
Treatment Satisfaction Survey
Time Frame: 18 weeks
The Thyroid Treatment Satisfaction Questionnaire Measures the treatment satisfaction. Possible measure 0 to 42; Higher the score, better the outcome (more satisfied the patient)
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Akrimax Pharmaceuticals

Investigators

  • Principal Investigator: Alex Tessnow, MD, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2017

Primary Completion (ACTUAL)

November 4, 2019

Study Completion (ACTUAL)

November 4, 2019

Study Registration Dates

First Submitted

October 21, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (ESTIMATE)

October 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 022015-044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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