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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 14, 2013
Last verified: June 2013
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
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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
  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
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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
  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 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
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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
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  More Information
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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
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 14, 2013
Health Authority: United States: Institutional Review Board