Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy
Primary Purpose
Thyroid Cancer, Postsurgical Hypothyroidism
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Levothyroxine
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Cancer focused on measuring levothyroxine
Eligibility Criteria
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
Sites / Locations
- University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Tablets
Gelcaps
Arm Description
Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)
Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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)
Full Information
NCT ID
NCT02946918
First Posted
October 21, 2016
Last Updated
November 4, 2020
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Akrimax Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02946918
Brief Title
Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy
Official Title
Levothyroxine Replacement With Liquid Gel Capsules or Tablets in Post-thyroidectomy Stage in Low Risk Differentiated Thyroid Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Terminating study as sponsor has sold the drug to another company
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
November 4, 2019 (Actual)
Study Completion Date
November 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Akrimax Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Postsurgical Hypothyroidism
Keywords
levothyroxine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tablets
Arm Type
Experimental
Arm Description
Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)
Arm Title
Gelcaps
Arm Type
Experimental
Arm Description
Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)
Intervention Type
Drug
Intervention Name(s)
Levothyroxine
Other Intervention Name(s)
Tirosint, Synthroid
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Patients in Each Group at Predefined Target TSH Range at 18 Weeks
Description
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.
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Mean Number of Dose Adjustments
Description
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
Time Frame
18 weeks
Title
Change in Mean Patient Quality of Life Score
Description
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.
Time Frame
Baseline,18 weeks
Title
Treatment Satisfaction Survey
Description
The Thyroid Treatment Satisfaction Questionnaire Measures the treatment satisfaction. Possible measure 0 to 42; Higher the score, better the outcome (more satisfied the patient)
Time Frame
18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Tessnow, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24896369
Citation
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.
Results Reference
background
PubMed Identifier
15671770
Citation
McMillan 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.
Results Reference
background
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Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy
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