Evaluation of Synthetic Thyrotropin Releasing Hormone (TRH) as a Treatment for Cancer-related Fatigue
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|ClinicalTrials.gov Identifier: NCT00790296|
Recruitment Status : Terminated (Interim analyses showed statistically and clinically significant results.)
First Posted : November 13, 2008
Results First Posted : May 3, 2011
Last Update Posted : December 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer-related Fatigue||Drug: Thyrotropin releasing hormone (TRH) Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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|
|Study Start Date :||December 2006|
|Primary Completion Date :||February 2010|
|Study Completion Date :||March 2010|
Experimental: Thyrotropin releasing hormone (TRH)
Drug: Thyrotropin releasing hormone (TRH)
0.5mg and 1.5mg
Placebo Comparator: Saline
- 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 ]1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790296
|United States, Connecticut|
|University of Connecticut Health Center|
|Farmington, Connecticut, United States, 06030|
|Principal Investigator:||Andrew Winokur, MD PhD||UConn Health|