Neoplasms

All Conditions

Gland and Hormone Related Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Hypothyroidism

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

All Drugs and Chemicals

Herbal and Botanical

Hormones

Synthroid will be administered with 12 ounces of black coffee for a period of 6 weeks.

Synthroid will be administered with 12 ounces of coffee and 2 ounces of 2% milk for a period of 6 weeks.

Synthroid will be administered with 12 ounces of black Lipton tea for a period of 6 weeks.

Synthroid will be administered with 12 ounces of water for a period of 6 weeks.

Taking Synthroid with 12 ounces of black coffee for 6 weeks.

Black Coffee

Taking Synthroid with 12 ounces of black coffee and 2 ounces of 2% milk for a period of 6 weeks.

Coffee with Milk

Taking Synthroid with 12 ounces of black tea for a period of 6 weeks.

Black Tea

Taking Synthroid with water for a period of 6 weeks.

Water

Dorota Krajewski, MD

The purpose of this study is to evaluate whether taking thyroid hormone medication with beverages other than water, decreases absorption of the medication by the intestine. Specifically we are interested in whether coffee, coffee with milk, or black tea affects how thyroid medication is absorbed by the body. Previous studies have suggested that taking thyroid hormone with coffee may interfere with the ability to absorb thyroid medicine. Given that many patients take their thyroid medicine with beverages other than water, and specifically with coffee or tea, understanding whether and how much coffee or tea may decrease thyroid hormone absorption is important for clinical practice.

This study will help determine the safest and most effective way for adults to take their thyroid medication and will guide medical practitioners in how to counsel their patients when they prescribe thyroid hormone.

Previous studies have suggested that taking thyroid replacement therapy with coffee potentially hinders its absorption. We already know that food especially a fiber-rich diet, cholestyramine resin, aluminum containing antacids, activated charcoal, and certain herbal remedies among others interfere with the ability to absorb thyroid medicine. These findings have prompted providers to advise patients to take their levothyroxine on an empty stomach in the morning. However, many patients take their thyroid medicine with their morning cup of coffee prior to eating breakfast. A small study has shown that Italian espresso coffee can decrease the absorption of levothyroxine, but the effect of American style coffee is not known. Given that the intestinal absorption of levothyroxine can be hindered by multiple substances and coffee is the most commonly consumed beverage worldwide, it is important to investigate what effect coffee may have on thyroid hormone absorption and thyroid function tests.

Using methods similar to those used in previous studies, this study will measure thyroid function tests in approximately 10-20 subjects (18-60 years of age) over a 6 hour period of time after taking their thyroid medication with the specified study beverage for a 6 week period. Subjects will be randomized to water, black coffee, coffee with milk, and black tea as four specified study beverages, with water serving as the control beverage. Each subject will be recruited to participate with each study beverage for a 6 week period of time in a total of four consecutive 6 week periods. Blood draws will occur at the end of each 6 week period on test days 1, 2, 3, and 4. The coffee will represent the most common household coffee brand, Folgers. Thyroid function tests with each beverage will be compared to thyroid function tests with water to determine if thyroid medication absorption is impaired by coffee, coffee with milk, or tea.

This study will help determine the safest and most efficacious way for adults to take their thyroid medication and will guide medical practitioners in how to counsel their patients when they prescribe thyroid replacement therapy.

The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma

The Effect of Coffee Consumption on the Intestinal Absorption of Levothyroxine Thyroid Hormone Replacement in Patients With Thyroid Carcinoma

1. change in TSH over 6 hours
2. peak change in TSH over 6 hours

To determine if taking Synthroid for 6 weeks with each of the prescribed study beverages results in a different baseline TSH, reflecting altered absorption of levothyroxine with each particular beverage.

1. Change in total T4 over 6 hours
2. Peak change in total T4 over 6 hours
3. area under the curve (AUC) for total T4

1. Change in free T4 over 6 hours
2. Peak change in free T4 over 6 hours
3. area under the curve (AUC) for free T4

1. Change in total T3 over 6 hours
2. Peak change in total T3 over 6 hours
3. area under the curve (AUC) for total T3

Georgetown University

Medstar Health Research Institute

Behaviors and Mental Disorders

Symptoms and General Pathology

Anxiety Disorders

Depressive Disorder

Fatigue

Depression

Comthyroid

Synthroid

The goal of this research is to compare the effects on psychological distress between T4 mono replacement group and T4/T3 combination replacement group after total thyroidectomy in thyroid cancer patients.

1. Subjects:

   * Psychologically distressed patients, such as depression, anxiety, and fatigue patient after total thyroidectomy with thyroid cancer are considered for participation. Screening of distress after total thyroidectomy is used HADS (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, and MDASI-F (MD Anderson Symptom Inventory -Fatigue) ≥ 4 for fatigue.
2. Randomization:

   * Using the table of random sampling numbers, patients assign to T4 mono replacement group or T4/T3 combination replacement group.
3. Evaluation for distress:

   * Assessment will be made baseline, 4 weeks, 12 weeks and 24 weeks to investigate change of psychological distress (depression, anxiety, and fatigue). Level of distress after thyroidectomy will determine using Hospital Anxiety and Depression Scale (HADS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) for depression or anxiety, and Brief Fatigue Inventory (BFI) for fatigue.

The Effects of T4 Versus T4/T3 on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients

The Effects of T4 Mono Replacement Versus T4/T3 Combination Replacement on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients; Prospective, Randomized, Double Blind, T4 Comparative Clinical Study

Change from baseline HADS total score at 24 weeks

Change from baseline MDASI-F score at 24 weeks

Change from baseline BDI total score at 24 weeks

Change from baseline BAI total score at 24 weeks

Change from baseline BFI total score at 24 weeks

Dongnam Institute of Radiological & Medical Sciences

Inje University

Professor

Nervous System Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

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

Levothyroxine

Liothyronine

Victor Levin, MD

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.

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.

Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors

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.

M.D. Anderson Cancer Center

Levothyroxine + Liothyronine

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Victor Levin, MD, BS / Professor

Memory function (RAVLT)

Attention (digit span)

Processing speed (digit symbol)

Executive function (trail making)

Motor dexterity (pegs/pegboard)

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

8 Weeks Post Therapy

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma	NCT01707056	Thyroid Carcino... Hypothyroidism	Black Coffee Coffee with Mil... Black Tea Water	18 Years - 60 Years	Medstar Health Research Institute
The Effects of T4 Versus T4/T3 on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients	NCT03024151	Thyroid Cancer Distress Depression Anxiety Fatigue	Comthyroid Synthroid	20 Years - 70 Years	Inje University
Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors	NCT00488644	Hypothyroidism Brain Tumor	Levothyroxine Liothyronine	18 Years -	M.D. Anderson Cancer Center
Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors	NCT00488644	Hypothyroidism Brain Tumor	Levothyroxine Liothyronine	18 Years -	M.D. Anderson Cancer Center
The Effects of T4 Versus T4/T3 on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients	NCT03024151	Thyroid Cancer Distress Depression Anxiety Fatigue	Comthyroid Synthroid	20 Years - 70 Years	Inje University

Spots Global Cancer Trial Database for synthroid

Every month we try and update this database with for synthroid cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for synthroid

Every month we try and update this database with for synthroid cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for synthroid cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.