Expired Study
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Farmington, Connecticut 06030


Purpose:

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.


Criteria:

Inclusion Criteria: - Patients with a diagnosis of cancer who have undergone or are currently undergoing radiation or chemotherapy therapy and are expected not to have any significant change in cancer treatment sessions during the study period - Provide written informed consent prior to initiation of any study-related procedures. - Male or female, 18 years of age or older with a diagnosis of cancer. - Able to understand and comply with the requirements of the study. Exclusion criteria: - Hospitalized patients. - Patients with an identifiable diagnosis of substance abuse or dependence within 6 months prior to evaluation (except those in full remission, or those with caffeine or nicotine dependence) as defined by DSM-IV criteria. - Patients with any of the following cardiovascular symptomatology. - Office systolic BP > 160mmHg and/or diastolic BP > 90mmHg. - Persons with a resting hear rate of > 100 beats per minute - Persons with a history of chronic stable angina - Persons with myocardial infarction or unstable angina or vascular surgery within 6 months - Persons with history of vaso-vagal or other syncopal episodes - Patients with any known clinically significant cardiac problems - Patients with any history of stroke or at significant risk for stroke. - Patients with a history of seizures - Patients with a history of asthma - Patients with any clinically significant unstable or inadequately treated co- morbid medical condition or patients currently on medications that would confound evaluation of CF (e.g. diabetes, CHF, history of other cancers) as judged by the investigator. - Patients with any clinically significant, unstable psychiatric disorder (except mild to moderate depressive or anxiety disorders) or patients on psychotropic medications that would confound CF assessment as judged by the investigator. Patients with history of depressive or anxiety disorders will not be excluded from the study - Patients with a history of illnesses or treatments that would be expected to significantly alter immune function (viz. HIV infection, systemic lupus erythematosus, patients taking immunosuppressive medications). - Patients with diseases or on medications that significantly affect the hypothalamic-pituitary-adrenocortical (HPA) axis function (viz. Cushings disease). - Pregnant patients, breastfeeding or plans to become pregnant during the study - Patients with known allergy to TRH - Any other condition, which, in the opinion of the investigator, would make the patient, unsuited for enrollment, confound CF evaluation or could interfere with the patient's participation in the study. - Patients with medically reversible causes of CF (viz., anemia, hypothyroidism, electrolyte abnormalities etc). - Patients with potentially treatable associated symptoms dominating the CF scenario such as pain, or sleep disturbances which may have a significant causal relationship to CF. - Patients identified as pregnant based on the pregnancy test during screening. - Patients physically unable to complete the walking test (WT) assessment or when the WT would increase risk for medical complications


Study is Available At:


Original ID:

05-269-2


NCT ID:

NCT00790296


Secondary ID:

601


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

UConn Health


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Interim analyses showed statistically and cl


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

11


Enrollment Type:

Actual


Overall Contact Information

Official Name:Andrew Winokur, MD PhD
Principal Investigator
UConn Health

Study Dates

Start Date:December 2006
Completion Date:March 2010
Completion Type:Actual
Primary Completion Date:February 2010
Primary Completion Type:Actual
Verification Date:December 2017
Last Changed Date:December 4, 2017
First Received Date:November 10, 2008
First Results Date:January 31, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion
Time Frame:Baseline and 7 hours post study medication infusion
Safety Issues:False
Description:1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.

Study Interventions

Intervention Type:Drug
Name:Thyrotropin releasing hormone (TRH)
Description:0.5mg and 1.5mg
Arm Name:Thyrotropin releasing hormone (TRH)
Intervention Type:Drug
Name:Placebo
Description:Saline
Arm Name:Saline

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Saline
Description:Placebo
Study Arm Type:Experimental
Arm Name:Thyrotropin releasing hormone (TRH)
Description:TRH

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:UConn Health
Agency Class:Other
Agency Type:Collaborator
Agency Name:Susan G. Komen Breast Cancer Foundation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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