Postsurgical Hypothyroidism, Thyroid Cancer
Conditions
Keywords
levothyroxine
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.
Interventions
DRUGLevothyroxine
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
Sponsors
Akrimax Pharmaceuticals
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients in Each Group at Predefined Target TSH Range at 18 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Dose Adjustments | 18 weeks | 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 |
| Change in Mean Patient Quality of Life Score | Baseline,18 weeks | 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. |
| Treatment Satisfaction Survey | 18 weeks | The Thyroid Treatment Satisfaction Questionnaire Measures the treatment satisfaction. Possible measure 0 to 42; Higher the score, better the outcome (more satisfied the patient) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tablets Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps | 6 |
| Gelcaps Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps | 8 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patient unblinded himself | 1 | 0 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Ran out of study medication | 0 | 1 |
Baseline characteristics
| Characteristic | Tablets | Gelcaps | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 8 |
| other Total, other adverse events | 4 / 6 | 3 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 8 |
Outcome results
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.
Time frame: 18 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tablets | Number of Patients in Each Group at Predefined Target TSH Range at 18 Weeks | 2 Participants |
| Gelcaps | Number of Patients in Each Group at Predefined Target TSH Range at 18 Weeks | 4 Participants |
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.
Time frame: Baseline,18 weeks
Population: Out of 6 people from the Tablet group, 1 did not complete the second survey. Out of 8 people from the Gelcap group, 3 people did not complete the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tablets | Change in Mean Patient Quality of Life Score | -1.2 score on a scale | Standard Deviation 12.99 |
| Gelcaps | Change in Mean Patient Quality of Life Score | -29.6 score on a scale | Standard Deviation 48.06 |
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
Time frame: 18 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tablets | Mean Number of Dose Adjustments | 2.0 The number of dose adjustments | Standard Deviation 0.63 |
| Gelcaps | Mean Number of Dose Adjustments | 1.25 The number of dose adjustments | Standard Deviation 1.04 |
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)
Time frame: 18 weeks
Population: Out of 6 people from the Tablet group, 1 did not complete the second survey. Out of 8 people from the Gelcap group, 3 people did not complete the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tablets | Treatment Satisfaction Survey | 39.2 score on a scale | Standard Deviation 3.7 |
| Gelcaps | Treatment Satisfaction Survey | 39 score on a scale | Standard Deviation 3 |