Study of Euthyroid Hypothyroxinemia in Metastatic Breast Carcinoma

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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. However, there are data suggesting that triiodothyronine (T3) may have benefits in preventing disease progression over l-thyroxine (T4).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aultman Health Foundation

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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, NYHA advanced [Class III/IV] CHF, 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