Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors

June 14, 2013 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levothyroxine + Liothyronine
Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
Drug: Levothyroxine
75 mcg by mouth (PO) Daily for 8 Weeks
Other Names:
  • Synthroid
Drug: Liothyronine
15 mcg PO Daily for 8 Weeks
Other Names:
  • Cytomel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline and after 8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Victor Levin, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 19, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimate)

June 20, 2007

Study Record Updates

Last Update Posted (Estimate)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 14, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-0804

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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