Thyroid Cancer Clinical Trial
Official title:
Levothyroxine Replacement With Liquid Gel Capsules or Tablets in Post-thyroidectomy Stage in Low Risk Differentiated Thyroid Cancer Patients
Verified date | November 2020 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 14 |
Est. completion date | November 4, 2019 |
Est. primary completion date | November 4, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | Akrimax Pharmaceuticals |
United States,
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. — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 18 weeks | |
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 | 18 weeks | |
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. | Baseline,18 weeks | |
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) | 18 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05774535 -
Prospective, Observational Study on the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
|
||
Withdrawn |
NCT04224792 -
Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors
|
N/A | |
Completed |
NCT01728623 -
A Study of E7080 in Subjects With Advanced Thyroid Cancer
|
Phase 2 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT02911155 -
Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
|
||
Recruiting |
NCT05025046 -
NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
|
||
Not yet recruiting |
NCT03978351 -
The Role of Midkine in Diagnosis of Thyroid Cancer
|
||
Completed |
NCT02658513 -
Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer
|
||
Terminated |
NCT02628535 -
Safety Study of MGD009 in B7-H3-expressing Tumors
|
Phase 1 | |
Withdrawn |
NCT01994200 -
Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients
|
Phase 1/Phase 2 | |
Completed |
NCT02375451 -
Effect of Childhood Radioiodine Therapy on Salivary Function
|
N/A | |
Terminated |
NCT01403324 -
Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer
|
N/A | |
Completed |
NCT00970359 -
Reacquisition of Radioactive Iodine (RAI) Uptake of RAI-Refractory Metastatic Thyroid Cancers by Pretreatment With the Selective MEK Inhibitor AZD6244
|
N/A | |
Completed |
NCT00439478 -
Dental Safety Profile of High-Dose Radioiodine Therapy
|
Phase 4 | |
Completed |
NCT00223158 -
Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer
|
N/A | |
Active, not recruiting |
NCT04544111 -
PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer
|
Phase 2 | |
Completed |
NCT04876287 -
Salivary dysfuncTion After Radioiodine Treatment
|
||
Recruiting |
NCT06073223 -
Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
|
N/A | |
Recruiting |
NCT06037174 -
Comparison of Quality of Life in Patients With Differentiated Thyroid Carcinoma Undergoing Different Surgery
|
||
Recruiting |
NCT04952493 -
Anlotinib or Penpulimab in Combination With RAI for DTC
|
Phase 2 |