Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors
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|ClinicalTrials.gov Identifier: NCT00488644|
Recruitment Status : Terminated (Slow accrual.)
First Posted : June 20, 2007
Results First Posted : July 17, 2012
Last Update Posted : June 24, 2013
- Assess whether combined treatment with Levothyroxine and Liothyronine improves learning and memory.
- Explore the relationship between T3 treatment and other domains of cognitive function, quality of life, and mood.
|Condition or disease||Intervention/treatment||Phase|
|Hypothyroidism Brain Tumor||Drug: Levothyroxine Drug: Liothyronine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Experimental: Levothyroxine + Liothyronine
Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
75 mcg by mouth (PO) Daily for 8 Weeks
Other Name: Synthroid
15 mcg PO Daily for 8 Weeks
Other Name: Cytomel
- Number of Participants Demonstrating Improvement With Impaired Neuro-cognitive Function (NCF) Based on Results of a Series Neuro-cognitive Exams Administered at Baseline and 8 Weeks After Liothyronine Therapy [ Time Frame: At baseline and after 8 weeks of treatment ]At baseline, each participant's scores for standardized/widely-used NCF exams are recorded (recalled words/objects/sequence repetition/etc per tests listed below). After 8 weeks liothyronine therapy, participants are tested again and scores compared to baseline scores. If the participant recalls more numbers/objects/sequence repetition faster/etc., than previous scores, this constitutes an improvement in NCF function for that individual. Scores are not compared to other participants. NCF tests: Memory by RAVLT (Rey Auditory Verbal Learning Test), scored by the number of words correctly recalled at different timepoints; Attention by Digit Span Exam (accurately repeating a sequence of numbers just spoken); Processing speed by Digit Symbol Exam (accurately matching numbers with associated symbols) Executive function by Trail Making Tests and Controlled Oral Word Association; Motor dexterity evaluated by correctly placing pegs in pegboards in a specified time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488644
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Victor Levin, MD||M.D. Anderson Cancer Center|