Status:
TERMINATED
Study of Euthyroid Hypothyroxinemia in Metastatic Breast Carcinoma
Lead Sponsor:
Aultman Health Foundation
Conditions:
Metastatic Breast Cancer
Thyroid Dysfunction
Eligibility:
All Genders
18-105 years
Phase:
PHASE2
Brief Summary
Up to one third of breast cancer patients have hypothyroidism or hyperthyroidism. L-thyroxine (T4), or Synthroid, is the most commonly prescribed agent for the management of hypothyroidism in the US. ...
Detailed Description
It is estimated that there are approximately 155,000 living with metastatic breast cancer in the US and the number is estimated to increase over the next years (SEER data). Although their median survi...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18
- Male or female with diagnosis of metastatic breast carcinoma and documented history of hypothyroidism .
- TSH level within normal range at baseline
- Life expectancy estimated \> 3 months
- Ability and willingness to provide informed consent
Exclusion
- Life expectancy estimated to be less than 3 months
- Is currently pregnant or intends to become pregnant during the duration of the study
- Active angina, New York Heart Association (NYHA) advanced \[Class III/IV\] congestive heart failure, or uncontrolled cardiac arrhythmia within 6 months of enrollment
- History of thyrotoxicosis
- History of adrenal insufficiency
- Hypersensitivity to any active or extraneous constituents in Triiodothyronine (T3)/liothyronine sodium
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03787303
Start Date
March 1 2019
End Date
March 9 2022
Last Update
May 13 2022
Active Locations (1)
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1
Aultman Medical Group Hematology and Oncology
Canton, Ohio, United States, 44710