Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy

Thyroid Cancer Clinical Trial

Official title:

Levothyroxine Replacement With Liquid Gel Capsules or Tablets in Post-thyroidectomy Stage in Low Risk Differentiated Thyroid Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02946918
• Other study ID #: STU 022015-044
• Status: Terminated
• Phase: Phase 4
• Start date: February 1, 2017
• Est. completion date: November 4, 2019

Study information

• Verified date: November 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: November 4, 2019
• Est. primary completion date: November 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypothyroidism
• Postsurgical Hypothyroidism
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Akrimax Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 weeks
Secondary	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	18 weeks
Secondary	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.	Baseline,18 weeks
Secondary	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)	18 weeks