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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

Tracking Information
First Submitted Date  ICMJE June 19, 2007
First Posted Date  ICMJE June 20, 2007
Results First Submitted Date  ICMJE March 22, 2012
Results First Posted Date  ICMJE July 17, 2012
Last Update Posted Date June 24, 2013
Study Start Date  ICMJE February 2006
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2013)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors
Official Title  ICMJE Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors
Brief Summary

Primary Objectives:

  1. Assess whether combined treatment with Levothyroxine and Liothyronine improves learning and memory.
  2. Explore the relationship between T3 treatment and other domains of cognitive function, quality of life, and mood.
Detailed Description

Hypothyroidism causes the body to not be able to produce enough thyroid hormones. Levothyroxine and liothyronine are synthetic (man-made) hormones that may help treat hypothyroidism by increasing the metabolism (activity) of cells of all tissues in the body. The combination treatment, given to patients with hypothyroidism, may help improve normal body and brain functioning.

Levothyroxine is a man-made type of hormone that is made and released by the thyroid gland (thyroxine [T4]). Liothyronine is also a man-made type of hormone, but it is made by the thyroid gland (triiodothyronine [T3]). Both levothyroxine and liothyronine effect different functions in the body that help regulate (control) the activity and amount of energy that cells use.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have your complete medical history recorded. You will have a neuropsychological evaluation (a series of tests that evaluate how well your brain is performing). This evaluation includes an interview, and tests will be performed to check your memory, language, and thinking abilities. You will have a neurological exam performed, which will include measurement of your weight, height, and performance status (how well you are able to perform daily activities). This will be done within 14 days before the start of this study.

You will have blood collected (about 2 tablespoons) for routine laboratory tests (free T4, total T3) for patients with hypothyroidism. You will also be given 4 questionnaires to fill out that will ask about your general QoL and changes in your mood. These questionnaires will take about 20 minutes total to complete.

If you are found to be eligible to take part in this study, you will receive your standard dose of levothyroxine (after you have your blood collected for laboratory tests and physical measurements taken) by mouth. You will receive liothyronine by mouth on Day 1 of this study and then have a neuro-cognitive test ( that evaluates how well your brain is performing). The dose of liothyronine you receive will depend on the dose of levothyroxine that you are already on.

Approximately 4 weeks after you start on the treatment, you will be called by a research data coordinator or research nurse who will ask you questions about any symptoms of hyperthyroidism that you may be having. This is in case your dose of liothyronine is too high and may need to be adjusted.

You will be receiving levothyroxine and liothyronine for up to 8 weeks. However, you will be taken off this study, if your disease gets worse or you experience any intolerable side effects.

You will be asked to return again to the hospital 8 weeks after your first visit for an end-of-study visit. You will have another neuropsychological evaluation performed. Blood (around 2 tablespoons) will again be collected to test the levels of free T4 and total T3 in your body. You will also have your physical measurements taken. You will receive another standard dose of levothyroxine. You will have another neurocognitive test performed, and you will be given 4 more questionnaires to evaluate your QoL and any changes in your mood. The questionnaires will take about 20 minutes total to complete.

Your participation in this study will be over after your end-of-study visit.

This is an investigational study. Liothyronine and levothyroxine each are approved by the FDA for hypothyroidism and are commercially available. However, the use of these drugs in combination is experimental. Up to 26 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypothyroidism
  • Brain Tumor
Intervention  ICMJE
  • Drug: Levothyroxine
    75 mcg by mouth (PO) Daily for 8 Weeks
    Other Name: Synthroid
  • Drug: Liothyronine
    15 mcg PO Daily for 8 Weeks
    Other Name: Cytomel
Study Arms  ICMJE Experimental: Levothyroxine + Liothyronine
Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
  • Drug: Levothyroxine
  • Drug: Liothyronine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 15, 2010)
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2007)
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients must have the diagnosis of hypothyroidism.
  • Patients must be already on thyroid hormone replacement.
  • Patients must be greater than or equal to 18 years old.
  • Patients must have a diagnosis of a primary or secondary brain tumor and must have received prior radiation.
  • Patients must have a life expectancy of at least 6 months.

Exclusion Criteria:

  • Previously established dementing illness.
  • Other medical conditions known to cause dementia.
  • Significant psychiatric illness.
  • Uncontrolled seizures.
  • Acute or chronic pulmonary disease.
  • Active severe infections.
  • Signs or symptoms of coronary artery disease.
  • History of congenital hypothyroidism, hyperthyroidism, thyroidectomy, 131I-therapy, or thyroid cancer.
  • Paroxysmal supraventricular tachycardia, or any serious unstable medical condition.
  • Inability to read and write in English.
  • Patients must not be taking any medications that interfere with thyroid hormone metabolism (Beta-Adrenergic Blocking Agents, Antiarrhythmic drugs, Antipsychotic Agents, Tricyclic Antidepressants, Amiodarone, Iodine, Lithium, and Alpha-Interferon).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00488644
Other Study ID Numbers  ICMJE 2005-0804
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Victor Levin, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP