Trial Outcomes & Findings for Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors (NCT NCT00488644)
NCT ID: NCT00488644
Last Updated: 2013-06-24
Results Overview
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.
TERMINATED
NA
12 participants
At baseline and after 8 weeks of treatment
2013-06-24
Participant Flow
Recruitment Period: February 16, 2006 to September 10, 2008. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
Levothyroxine + Liothyronine
Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Levothyroxine + Liothyronine
Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
|
|---|---|
|
Overall Study
Not Eligible
|
1
|
|
Overall Study
Not Evaluable
|
1
|
Baseline Characteristics
Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors
Baseline characteristics by cohort
| Measure |
Levothyroxine + Liothyronine
n=12 Participants
Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
|
|---|---|
|
Age Continuous
|
44 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline and after 8 weeks of treatmentAt 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.
Outcome measures
| Measure |
8 Weeks Post Therapy
n=10 Participants
Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks.
|
|---|---|
|
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
Memory function (RAVLT)
|
0 participants
|
|
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
Attention (digit span)
|
0 participants
|
|
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
Processing speed (digit symbol)
|
1 participants
|
|
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
Executive function (trail making)
|
3 participants
|
|
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
Motor dexterity (pegs/pegboard)
|
1 participants
|
Adverse Events
Levothyroxine + Liothyronine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Levothyroxine + Liothyronine
n=12 participants at risk
Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
|
|---|---|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.3%
1/12 • Number of events 1 • 21 months
|
|
Skin and subcutaneous tissue disorders
Puritis/Itching
|
8.3%
1/12 • Number of events 1 • 21 months
|
|
Metabolism and nutrition disorders
Metabolic/Lab
|
8.3%
1/12 • Number of events 1 • 21 months
|
|
Psychiatric disorders
Mood Alteration (Anxiety)
|
8.3%
1/12 • Number of events 1 • 21 months
|
|
Psychiatric disorders
Mood Alteration (Depression)
|
8.3%
1/12 • Number of events 1 • 21 months
|
|
Cardiac disorders
Palpitations
|
8.3%
1/12 • Number of events 1 • 21 months
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
8.3%
1/12 • Number of events 1 • 21 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place