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

This study has been terminated.

( Interim analyses showed statistically and clinically significant results. )

Study NCT00790296 Information provided by University of Connecticut Health Center

First Received on November 10, 2008. Last Updated on April 5, 2011 History of Changes

Results First Received: January 31, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
Condition:	Cancer-related Fatigue
Interventions:	Drug: Thyrotropin releasing hormone (TRH) Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited per referrals from oncology clinics at UCHC and Gray Cancer Center at Hartford Hospital

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two participants signed informed consent but was not randomized as she did not meet study eligibility criteria

Reporting Groups

	Description
TRH Then Saline	TRH (0.5mg) given first followed by Saline
Saline Then TRH	Saline given first followed by TRH (0.5 mg)

Participant Flow: Overall Study

	TRH Then Saline	Saline Then TRH
STARTED	5	6
COMPLETED	4	4
NOT COMPLETED	1	2
Did not meet study eligibility criteria	1	1
Adverse Event	0	1

Baseline Characteristics

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Reporting Groups

	Description
TRH Then Saline	TRH (0.5mg) given first followed by Saline
Saline Then TRH	Saline given first followed by TRH (0.5 mg)

Baseline Measures

	TRH Then Saline	Saline Then TRH	Total
Number of Participants [units: participants]	5	6	11
Age [units: years] Mean ± Standard Deviation	58 ± 9.4	58 ± 9.4	58 ± 9.4
Gender [units: participants]
Female	5	5	10
Male	0	1	1

Outcome Measures

1. Primary:

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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitation: small sample size

Results Point of Contact:

Name/Title: Andrew Winokur MD PhD
Organization: University of Connecticut Health Center
phone: 860-679-6775
e-mail: awinokur@uchc.edu

No publications provided

Responsible Party:	Andrew Winokur MD PhD, University of Connecticut Health Center
ClinicalTrials.gov Identifier:	NCT00790296 History of Changes
Other Study ID Numbers:	05-269-2, 601
Study First Received:	November 10, 2008
Results First Received:	January 31, 2011
Last Updated:	April 5, 2011
Health Authority:	United States: Food and Drug Administration