Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Texas Southwestern Medical Center
With
Akrimax Pharmaceuticals
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
