This phase IV trial studies how well levothyroxine sodium liquid gel capsules work compared to tablets in treating patients with stage I-II differentiated thyroid cancer after surgery. Hormone replacement therapy, such as levothyroxine sodium, may help control thyroid cancer in patients after surgery. It is not yet known whether giving levothyroxine sodium tablets or liquid gel capsules may work better in treating patients with thyroid cancer after surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02946918.
PRIMARY OBJECTIVES:
I. To compare the use of levothyroxine in liquid gel capsules to tablet form for thyroid stimulating hormone (TSH) suppression (target 0.1-0.5 MIU/L) following thyroidectomy for presumed stage I/II differentiated thyroid cancer.
SECONDARY OBJECTIVES:
I. To quantify the mean number of dose adjustments, and compare the two study agent group outcomes.
II. To assess and compare quality of life differences between study groups using scores on Thyroid version Quality of Life Questionnaire (QoL-Thyroid) and Underactive Thyroid Treatment Satisfaction Questionnaire (ThyTSQ) surveys.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients receive levothyroxine sodium liquid gel capsules orally (PO) once daily (QD) for 18 weeks in the absence of disease progression or unaccepted toxicity.
GROUP II: Patients receive levothyroxine sodium tablets PO QD for 18 weeks in the absence of disease progression or unaccepted toxicity.
After completion of study treatment, patients are followed up periodically.
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorAlex Tessnow
