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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

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.

Condition or disease Intervention/treatment Phase
Hypothyroidism Brain Tumor Drug: Levothyroxine Drug: Liothyronine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors
Study Start Date : February 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

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 Name: Synthroid

Drug: Liothyronine
15 mcg PO Daily for 8 Weeks
Other Name: Cytomel

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00488644

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Victor Levin, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00488644    
Other Study ID Numbers: 2005-0804
First Posted: June 20, 2007    Key Record Dates
Results First Posted: July 17, 2012
Last Update Posted: June 24, 2013
Last Verified: June 2013
Keywords provided by M.D. Anderson Cancer Center:
Brain Tumor
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thyroid Diseases
Endocrine System Diseases