Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 20 of 82 for:    "Hypothyroidism"

Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors

This study has been terminated.
(Slow accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00488644
First received: June 19, 2007
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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 Intervention
Hypothyroidism
Brain Tumor
Drug: Levothyroxine
Drug: Liothyronine

Study Type: Interventional
Study Design: 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:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


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
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Victor Levin, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00488644     History of Changes
Other Study ID Numbers: 2005-0804
Study First Received: June 19, 2007
Results First Received: March 22, 2012
Last Updated: June 14, 2013
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:
Hypothyroidism
Brain Neoplasms
Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Endocrine System Diseases
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Thyroid Diseases

ClinicalTrials.gov processed this record on November 19, 2014