Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors

NCT00488644 | Terminated Results

• 1 other identifier: 2005-0804
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

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

Conditions

Hypothyroidism; Brain Tumor

Keywords

Hypothyroidism; Brain Tumor; Levothyroxine; Liothyronine; Synthroid; Cytomel

Outcome Measures

Primary Outcomes (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

  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

Study Arms (1)

Levothyroxine + Liothyronine

EXPERIMENTAL

Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks

Drug: Levothyroxine; Drug: Liothyronine

Interventions

Levothyroxine DRUG

75 mcg by mouth (PO) Daily for 8 Weeks

Also known as: Synthroid

Levothyroxine + Liothyronine

Liothyronine DRUG

15 mcg PO Daily for 8 Weeks

Also known as: Cytomel

Levothyroxine + Liothyronine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Hypothyroidism; Brain Neoplasms

Interventions

Thyroxine; Triiodothyronine

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Thyronines

Results Point of Contact

• Title: Victor Levin, MD, BS / Professor
• Organization: UT MD Anderson Cancer Center

kuhunter@mdanderson.org

Study Officials

• Victor Levin, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2007
• First Posted: June 20, 2007
• Study Start: February 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: June 24, 2013
• Results First Posted: July 17, 2012

Record last verified: 2013-06

Locations

US (1)