HypothyroidismNCT00488644
Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors
A study testing Levothyroxine and Liothyronine in people with Hypothyroidism and Brain Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothyroidism, Brain Tumor
- What is being tested?
- Levothyroxine and Liothyronine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Mar 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previously established dementing illness.
- Other medical conditions known to cause dementia.
- Significant psychiatric illness.
- Uncontrolled seizures.
- Acute or chronic pulmonary disease.
- Active severe infections.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Hypothyroidism causes the body to not be able to produce enough thyroid hormones. Levothyroxine and liothyronine are synthetic (man-made) hormones that may help treat hypothyroidism by increasing the metabolism (activity) of cells of all tissues in the body. The combination treatment, given to patients with hypothyroidism, may help improve normal body and brain functioning.
Levothyroxine is a man-made type of hormone that is made and released by the thyroid gland (thyroxine [T4]). Liothyronine is also a man-made type of hormone, but it is made by the thyroid gland (triiodothyronine [T3]). Both levothyroxine and liothyronine effect different functions in the body that help regulate (control) the activity and amount of energy that cells use.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have your complete medical history recorded. You will have a neuropsychological evaluation (a series of tests that evaluate how well your brain is performing). This evaluation includes an interview, and tests will be performed to check your memory, language, and thinking abilities. You will have a neurological exam performed, which will include measurement of your weight, height, and performance status (how well you are able to perform daily activities). This will be done within 14 days before the start of this study.
You will have blood collected (about 2 tablespoons) for routine laboratory tests (free T4, total T3) for patients with hypothyroidism. You will also be given 4 questionnaires to fill out that will ask about your general QoL and changes in your mood. These questionnaires will take about 20 minutes total to complete.
If you are found to be eligible to take part in this study, you will receive your standard dose of levothyroxine (after you have your blood collected for laboratory tests and physical measurements taken) by mouth. You will receive liothyronine by mouth on Day 1 of this study and then have a neuro-cognitive test ( that evaluates how well your brain is performing). The dose of liothyronine you receive will depend on the dose of levothyroxine that you are already on.
Approximately 4 weeks after you start on the treatment, you will be called by a research data coordinator or research nurse who will ask you questions about any symptoms of hyperthyroidism that you may be having. This is in case your dose of liothyronine is too high and may need to be adjusted.
You will be receiving levothyroxine and liothyronine for up to 8 weeks. However, you will be taken off this study, if your disease gets worse or you experience any intolerable side effects.
You will be asked to return again to the hospital 8 weeks after your first visit for an end-of-study visit. You will have another neuropsychological evaluation performed. Blood (around 2 tablespoons) will again be collected to test the levels of free T4 and total T3 in your body. You will also have your physical measurements taken. You will receive another standard dose of levothyroxine. You will have another neurocognitive test performed, and you will be given 4 more questionnaires to evaluate your QoL and any changes in your mood. The questionnaires will take about 20 minutes total to complete.
Your participation in this study will be over after your end-of-study visit.
This is an investigational study. Liothyronine and levothyroxine each are approved by the FDA for hypothyroidism and are commercially available. However, the use of these drugs in combination is experimental. Up to 26 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Hypothyroidism, Brain Tumor
- Being tested
- Levothyroxine, Liothyronine
- Keywords
- Hypothyroidism, Brain Tumor, Levothyroxine, Liothyronine, Synthroid, Cytomel
- Medical subject headings
- Hypothyroidism, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxineDrug
Also called Synthroid
75 mcg by mouth (PO) Daily for 8 Weeks
LiothyronineDrug
Also called Cytomel
15 mcg PO Daily for 8 Weeks
| Study group | Role | What they receive |
|---|---|---|
| Levothyroxine + Liothyronine | Experimental | Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks Receives: Drug: Levothyroxine; Drug: Liothyronine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and after 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startFeb 2006
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victor Levin, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488644
- Sponsor's protocol ID
- 2005-0804
- Status last verified
- Jun 2013
- First submitted
- 19 Jun 2007
- Last updated
- 24 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors
- ClinicalTrials.gov ID
- NCT00488644
- Acronym / sponsor ID
- 2005-0804
- Conditions
- Hypothyroidism, Brain Tumor
- Keywords
- Hypothyroidism, Brain Tumor, Levothyroxine, Liothyronine, Synthroid, Cytomel
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 20 Jun 2007 (estimated)
- Results
- Posted 17 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypothyroidism causes the body to not be able to produce enough thyroid hormones. Levothyroxine and liothyronine are synthetic (man-made) hormones that may help treat hypothyroidism by increasing the metabolism (activity) of cells of all tissues in the body. The combination treatment, given to patients with hypothyroidism, may help improve normal body and brain functioning.
Levothyroxine is a man-made type of hormone that is made and released by the thyroid gland (thyroxine [T4]). Liothyronine is also a man-made type of hormone, but it is made by the thyroid gland (triiodothyronine [T3]). Both levothyroxine and liothyronine effect different functions in the body that help regulate (control) the activity and amount of energy that cells use.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have your complete medical history recorded. You will have a neuropsychological evaluation (a series of tests that evaluate how well your brain is performing). This evaluation includes an interview, and tests will be performed to check your memory, language, and thinking abilities. You will have a neurological exam performed, which will include measurement of your weight, height, and performance status (how well you are able to perform daily activities). This will be done within 14 days before the start of this study.
You will have blood collected (about 2 tablespoons) for routine laboratory tests (free T4, total T3) for patients with hypothyroidism. You will also be given 4 questionnaires to fill out that will ask about your general QoL and changes in your mood. These questionnaires will take about 20 minutes total to complete.
If you are found to be eligible to take part in this study, you will receive your standard dose of levothyroxine (after you have your blood collected for laboratory tests and physical measurements taken) by mouth. You will receive liothyronine by mouth on Day 1 of this study and then have a neuro-cognitive test ( that evaluates how well your brain is performing). The dose of liothyronine you receive will depend on the dose of levothyroxine that you are already on.
Approximately 4 weeks after you start on the treatment, you will be called by a research data coordinator or research nurse who will ask you questions about any symptoms of hyperthyroidism that you may be having. This is in case your dose of liothyronine is too high and may need to be adjusted.
You will be receiving levothyroxine and liothyronine for up to 8 weeks. However, you will be taken off this study, if your disease gets worse or you experience any intolerable side effects.
You will be asked to return again to the hospital 8 weeks after your first visit for an end-of-study visit. You will have another neuropsychological evaluation performed. Blood (around 2 tablespoons) will again be collected to test the levels of free T4 and total T3 in your body. You will also have your physical measurements taken. You will receive another standard dose of levothyroxine. You will have another neurocognitive test performed, and you will be given 4 more questionnaires to evaluate your QoL and any changes in your mood. The questionnaires will take about 20 minutes total to complete.
Your participation in this study will be over after your end-of-study visit.
This is an investigational study. Liothyronine and levothyroxine each are approved by the FDA for hypothyroidism and are commercially available. However, the use of these drugs in combination is experimental. Up to 26 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levothyroxine + Liothyronine | Experimental | Drug: Levothyroxine, Drug: LiothyronineLevothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- Previously established dementing illness.
- Other medical conditions known to cause dementia.
- Significant psychiatric illness.
- Uncontrolled seizures.
- Acute or chronic pulmonary disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevothyroxineAlso: Synthroid75 mcg by mouth (PO) Daily for 8 Weeks | Drug | Levothyroxine + Liothyronine |
| LiothyronineAlso: Cytomel15 mcg PO Daily for 8 Weeks | Drug | Levothyroxine + Liothyronine |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Levin, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levothyroxine and Liothyronine in people with Hypothyroidism and Brain Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.