Status:
COMPLETED
Metabolic Effects of Synthetic Thyroid Hormone for Thyroid Cancer Treatment
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Malignant Struma Ovarii
Papillary Thyroid Cancer
Eligibility:
All Genders
18-99 years
Brief Summary
Background: \- Thyroid hormone is produced by the thyroid gland, an organ at the base of the neck. Thyroid hormone controls the body's metabolism and the function of many organs. The thyroid gland pr...
Detailed Description
In human adults thyroid hormone action plays a critical role in the modulation of metabolism and the function of virtually all organ/systems. The specificity of the hormonal action is ultimately the r...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects will be adult volunteers older than age 18 who underwent total thyroidectomy for the treatment of differentiated thyroid cancer, previously undergone radioactive iodine ablation of the thyroid gland remnant, with clinical indication for withdrawal from thyroid hormone replacement therapy in preparation for nuclear medicine imaging or therapeutic procedures with radioactive iodine. The patient population will be recruited from the participants in the 77-DK-0096 natural history protocol: Studies on Thyroid Nodules and Thyroid Cancer , PI Dr.Joanna Klubo-Gwiezdzinska and from the 10-C-0102 natural history protocol: Clinical and Genetic Studies in Familial Non-Medullary Thyroid Cancer , PI Electron Kebebew.
- EXCLUSION CRITERIA:
- Significant thyroid residual greater than 5 gm as measure by ultrasound or greater than 5 percent uptake at 24 H on (123) I pre-treatment thyroid scan.
- Renal insufficiency or estimated creatinine clearance less than or equal to 60 mL/min/1.73M(2) BSA by MDRD equation before thyroid hormone withdrawal.
- Liver disease or ALT \>2.5 times the upper laboratory reference limit.
- Pharmacologic therapy for the treatment of psychiatric conditions.
- History of, and/or current coronary artery disease.
- Current history or symptoms compatible with psychosis or major depression (including history of hospitalization for depression, history of attempted suicide, history of suicidal ideation). Use of antipsychotic medications.
- History of drug or alcohol abuse within the last year; current use of illicit drugs or alcohol abuse (CAGE\>3).
- Pregnancy (women of child-bearing potential must have a negative pregnancy test prior to inclusion) or use of hormonal contraceptives.
- Known allergy to L-T3.
- Current use of prescription medication or certain non-prescription medications and dietary supplements known to affect thyroid function and/or metabolism, or alter the pharmacokinetics of L-T3.
- Inability or unwillingness to follow the low-iodine, metabolic diet or non-compliance to the L-T3 administration regimen.
- The presence of persistent diarrhea or malabsorption syndromes that would interfere with the patient s ability to adequately absorb drugs.
- Inability to obtain venous access for sample collection, or basal hemoglobin of less than or equal to 10 g/dL.
- Low functional status (ECOG Performance Status \> 2)
Exclusion
Key Trial Info
Start Date :
September 20 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 12 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01441154
Start Date
September 20 2011
End Date
December 12 2013
Last Update
September 28 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892