Symptoms and General Pathology

All Conditions

Fatigue

All Drugs and Chemicals

Hormones

Thyrotropin-Releasing Hormone

Hormone Antagonists

Thyrotropin releasing hormone (TRH)

Placebo

Andrew Winokur, MD PhD

The primary objective of the study is to evaluate thyrotropin releasing hormone (TRH) as a treatment for cancer-related fatigue.

The central hypothesis of this pilot study is that TRH is more efficacious than placebo in alleviating cancer-related fatigue in patients with breast or prostate cancer.

Evaluation of Synthetic Thyrotropin Releasing Hormone (TRH) as a Treatment for Cancer-related Fatigue

A Pilot, Randomized Double-Blind Placebo-Controlled Crossover Study of Synthetic Thyrotropin Releasing Hormone (TRH) Administration for the Treatment of Fatigue in Patients With Cancer

1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.

Susan G. Komen Breast Cancer Foundation

Hollfelder foundation

UConn Health

TRH given as 0.5mg and 1.5mg intravenously

Thyrotropin-releasing Hormone (TRH)

Saline

TRH (0.5mg) given first followed by Saline

TRH Then Saline

Saline given first followed by TRH (0.5 mg)

Saline Then TRH

Total

Age, Continuous

Sex: Female, Male

Andrew Winokur MD PhD

Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion

Overall Study

Neoplasms

Gland and Hormone Related Diseases

Rare Diseases

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Generalized Resistance to Thyroid Hormone

Study subjects will be given 200mcg of TRH as a single intravenous (IV) bolus in endocrine clinic on Day 1 and Day 5. LT3 will be administered orally, twice a day (12 hours apart i.e. 8 AM and 8 PM) at a dosage of 10 mcg on Day 2-4. Levothyroxine will be taken after the TRH stimulation tests on Day 1 and day 5. Levothyroxine will be taken on Days 2-4 of the study. \*Patients will take their own LT4 that they are prescribed by their endocrinologist. The dose of Levothyroxine is titrated for each patient.

TRH administration will be given as a 200-mcg single IV bolus on Day 1 and Day 5.

Thyrotropin Releasing Hormone (TRH)

Patients maintenance dose of levothyroxine will be taken throughout the study. On Day

1 and Day 5, the levothyroxine will be taken after the TRH test is complete. On Days 2- 4, the levothyroxine will be taken in the morning.

levothyroxine

Administer standardized Hypothyroidism QOL questionnaire.

Hypothyroidism QOL questionnaire

Stephanie Fish, MD

The purpose of this study is to find out whether people who have had thyroid cancer develop resistance to treatment with thyroid hormones after having received high doses of thyroid drugs for many years.

This is a prospective, single center, pilot study of the hypothalamic-pituitary-thyroid axis in adult patients with thyroid cancer.

Study of Resistance to Thyroid Hormone After Long-term Exposure in People With Thyroid Cancer

Evaluation of The Development of Central Resistance to Thyroid Hormone After Prolonged Exposure to Excess Thyroid Hormone in Thyroid Cancer Patients

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

in response to TRH stimulation between day 1 (baseline) and day 5 after three days of high dose LT3 treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Synthetic Thyrotropin Releasing Hormone (TRH) as a Treatment for Cancer-related Fatigue	NCT00790296	Cancer-related ...	Thyrotropin rel... Placebo	18 Years -	UConn Health
Study of Resistance to Thyroid Hormone After Long-term Exposure in People With Thyroid Cancer	NCT04868045	Thyroid Cancer	Thyrotropin Rel... levothyroxine Hypothyroidism ...	18 Years -	Memorial Sloan Kettering Cancer Center
Evaluation of Synthetic Thyrotropin Releasing Hormone (TRH) as a Treatment for Cancer-related Fatigue	NCT00790296	Cancer-related ...	Thyrotropin rel... Placebo	18 Years -	UConn Health

Spots Global Cancer Trial Database for thyrotropin releasing hormone (trh)