Text Size

Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors

This study has been terminated.
(Slow accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00488644
First received: June 19, 2007
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
Results First Received: March 22, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hypothyroidism
Brain Tumor
Interventions: Drug: Levothyroxine
Drug: Liothyronine

  Participant Flow
  Hide 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 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
  Description
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  
STARTED     12  
COMPLETED     10  
NOT COMPLETED     2  
Not Eligible                 1  
Not Evaluable                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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

Baseline Measures
    Levothyroxine + Liothyronine  
Number of Participants  
[units: participants]
 		  12  
Age  
[units: years]
Median ( Full Range ) 		  44  
  ( 33 to 63 )  
Gender  
[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 NCF (Neuro-cognitive Function) Based on Results of a Series Neuro-cognitive Exams Administered at Baseline and Again 8 Weeks After Liothyronine Therapy   [ Time Frame: At baseline and after 8 weeks of treatment ]
  Show Outcome Measure 1


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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


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.  


Results Point of Contact:  
Name/Title: Victor Levin, MD, BS / Professor
Organization: UT MD Anderson Cancer Center
e-mail: kuhunter@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00488644     History of Changes
Other Study ID Numbers: 2005-0804
Study First Received: June 19, 2007
Results First Received: March 22, 2012
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board