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Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors


N/A
18 Years
N/A
Not Enrolling
Both
Hypothyroidism, Brain Tumor

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Trial Information

Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors


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.


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).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

At baseline and after 8 weeks of treatment

Safety Issue:

No

Principal Investigator

Victor Levin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2005-0804

NCT ID:

NCT00488644

Start Date:

February 2006

Completion Date:

March 2010

Related Keywords:

  • Hypothyroidism
  • Brain Tumor
  • Hypothyroidism
  • Brain Tumor
  • Levothyroxine
  • Liothyronine
  • Synthroid
  • Cytomel
  • Brain Neoplasms
  • Hypothyroidism

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030