Clinical trial NCT02946918: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Thyroid Cancer
Postsurgical Hypothyroidism
Keywords: levothyroxine
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Akrimax Pharmaceuticals
First posted: 2016-10-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients in Each Group at Predefined Target TSH Range at 18 Weeks
timeFrame: 18 weeks
Secondary outcomes:
measure: Mean Number of Dose Adjustments
timeFrame: 18 weeks
measure: Change in Mean Patient Quality of Life Score
timeFrame: Baseline,18 weeks
measure: Treatment Satisfaction Survey
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Alex Tessnow, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.