Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Endocrine, Endocrine, Thyroid Cancer |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/4/2018 |
| Start Date: | February 1, 2017 |
| End Date: | January 31, 2021 |
| Contact: | Lindsay Jacobs, PA |
| Email: | lindsay.jacobs@utsouthwestern.edu |
| Phone: | 214-645-2800 |
Levothyroxine Replacement With Liquid Gel Capsules or Tablets in Post-thyroidectomy Stage in Low Risk Differentiated Thyroid Cancer Patients
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.
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.
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 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.
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 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.
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
We found this trial at
1
site
1801 Inwood Rd
Dallas, Texas 75390
Dallas, Texas 75390
(214) 645-3300
Phone: 214-645-2800
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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