MDACC Study Summary 2005-0804 (Archived)

Study Summary
No. 2005-0804:.......Brain......Victor Levin......Neuro Oncology

Study Summary Title



Study Summary Number:	2005-0804

Study Title:	COMBINED LEVOTHYROXINE/LIOTHYRONINE SUPPLEMENTATION IN HYPOTHYROID PATIENTS WITH BRAIN TUMORS

Physician

New Patient Referral



Name:	Victor Levin	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Neuro Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-8297 Contact us about clinical trials

General Information



Disease Group:	Brain	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Every 4 weeks

Treatment Agents:	Levothyroxine Liothyronine	Home Care:	Administration of Levothyroxine and Liothyronine

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to find out if the combination of Synthroid (levothyroxine) and Cytomel (liothyronine) is effective in improving learning ability and memory (neurocognitive function), quality of life (QOL), and mood in patients with hypothyroidism due to brain tumors. The safety of this combination treatment will also be studied.

Study Objectives / Outcomes

1.1 Assess whether combined treatment with Levothyroxine and Liothyronine improves learning and memory.

1.2 Explore the relationship between T3 treatment and other domains of cognitive function, quality of life, and mood.

Study Status Information



Study Activation / Registration Date:	02/16/2006

IRB Review and Approval Date:	12/21/2005

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) All patients must have the diagnosis of hypothyroidism.

2) Patients must be already on thyroid hormone replacement.

3) Patients must be greater than or equal to 18 years old.

4) Patients must have a diagnosis of a primary or secondary brain tumor and must have received prior radiation.

5) Patients must have a life expectancy of at least 6 months.

Exclusion Criteria:

1) Previously established dementing illness.

2) Other medical conditions known to cause dementia.

3) Significant Psychiatric illness

4) Uncontrolled seizures.

5) Acute or chronic pulmonary disease.

6) Active severe infections.

7) Signs or symptoms of coronary artery disease.

8) History of congenital hypothyroidism, hyperthyroidism, thyroidectomy, 131I-therapy, or thyroid cancer.

9) Paroxysmal supraventricular tachycardia, or any serious unstable medical condition.

10) Inability to read and write in English.

11) Patients must not be taking any medications that inferfere with thyroid hormone metabolism (Beta-Adrenergic Blocking Agents, Antiarrhythmic drugs, Antipsychotic Agents, Tricyclic Antidepressants, Amiodarone, Iodine, Lithrium, and Alpha-Interferon).

Links

Registration Number: NCT00488644
Study Information on Clinical Trials Registry (clinicaltrials.gov)