Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors
This study has been terminated.
(Slow accrual.)
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00488644
First received: June 19, 2007
Last updated: June 13, 2012
Last verified: June 2012
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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: | 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 NCF (Neuro-cognitive Function) Based on Results of a Series Neuro-cognitive Exams Administered at Baseline and Again 8 Weeks After Liothyronine Therapy [ Time Frame: At baseline and after 8 weeks of treatment ] [ Designated as safety issue: No ]NCF exams administered before and after 8 weeks liothyronine therapy to measure: 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
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 13, 2012 |
| 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 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 21, 2013