Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00488644
Recruitment Status : Terminated (Slow accrual.)
First Posted : June 20, 2007
Results First Posted : July 17, 2012
Last Update Posted : June 24, 2013
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hypothyroidism
Brain Tumor
Interventions: Drug: Levothyroxine
Drug: Liothyronine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: February 16, 2006 to September 10, 2008. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Levothyroxine + Liothyronine Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks

Participant Flow:   Overall Study
    Levothyroxine + Liothyronine
Not Eligible                1 
Not Evaluable                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Levothyroxine + Liothyronine Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks

Baseline Measures
   Levothyroxine + Liothyronine 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (33 to 63) 
[Units: Participants]
Female   9 
Male   3 
Region of Enrollment 
[Units: Participants]
United States   12 

  Outcome Measures

1.  Primary:   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 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Victor Levin, MD, BS / Professor
Organization: UT MD Anderson Cancer Center

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00488644     History of Changes
Other Study ID Numbers: 2005-0804
First Submitted: June 19, 2007
First Posted: June 20, 2007
Results First Submitted: March 22, 2012
Results First Posted: July 17, 2012
Last Update Posted: June 24, 2013