Trial Outcomes & Findings for Evaluation of Synthetic Thyrotropin Releasing Hormone (TRH) as a Treatment for Cancer-related Fatigue (NCT NCT00790296)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Baseline and 7 hours post study medication infusion

Results posted on

2017-12-28

Patients were recruited per referrals from oncology clinics at UCHC and Gray Cancer Center at Hartford Hospital

Two participants signed informed consent but was not randomized as she did not meet study eligibility criteria

Participant milestones
Measure	TRH Then Saline TRH (0.5mg) given first followed by Saline	Saline Then TRH Saline given first followed by TRH (0.5 mg)
Overall Study STARTED	5	6
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal
Measure	TRH Then Saline TRH (0.5mg) given first followed by Saline	Saline Then TRH Saline given first followed by TRH (0.5 mg)
Overall Study Did not meet study eligibility criteria	1	1
Overall Study Adverse Event	0	1

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

Baseline characteristics by cohort
Measure	TRH Then Saline n=5 Participants TRH (0.5mg) given first followed by Saline	Saline Then TRH n=6 Participants Saline given first followed by TRH (0.5 mg)	Total n=11 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 9.4 • n=93 Participants	58 years STANDARD_DEVIATION 9.4 • n=4 Participants	58 years STANDARD_DEVIATION 9.4 • n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants

Timeframe: Baseline and 7 hours post study medication infusion

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

Outcome measures
Measure	Thyrotropin-releasing Hormone (TRH) n=4 Participants TRH given as 0.5mg and 1.5mg intravenously	Saline n=4 Participants Saline given Intravenously
Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion	14.67 Scores on a scale Standard Deviation 21.1	-1.67 Scores on a scale Standard Deviation 16

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Connecticut Health Center

Phone: 860-679-6775