Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors

This study has been terminated.

( Slow accrual. )

First Received on June 19, 2007. Last Updated on April 15, 2010 History of Changes

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00488644

Purpose

Primary Objectives:

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

Condition	Intervention
Hypothyroidism Brain Tumor	Drug: Levothyroxine Drug: Liothyronine

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

Drug Information available for: Levothyroxine Levothyroxine sodium Liothyronine sodium Liothyronine

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Patient RAVLT (Rey Auditory Verbal Learning Test) [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	February 2006
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Levothyroxine + Liothyronine	Drug: Levothyroxine 75 mcg by mouth (PO) Daily x 8 Weeks Other Name: Synthroid Drug: Liothyronine 15 mcg PO Daily x 8 Weeks Other Name: Cytomel

Eligibility

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488644

Locations

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Victor Levin, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Victor Levin, MD/Professor, U.T.M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00488644 History of Changes
Other Study ID Numbers:	2005-0804
Study First Received:	June 19, 2007
Last Updated:	April 15, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Hypothyroidism
Brain Tumor
Levothyroxine

Liothyronine
Synthroid
Cytomel

Additional relevant MeSH terms:

Brain Neoplasms
Hypothyroidism
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 24, 2012