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

Plain-language guide to NCT00790296: phase 2 randomized trial of TRH (Thyrotropin-Releasing Hormone), 11 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00790296
Phase: phase 2
Status: terminated early
Start: 2006-12
Completion (planned or actual): 2010-02
Participants: 11 (actual)
Design: randomized, triple-blind, supportive_care
Conditions studied: Cancer-related Fatigue
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested TRH (Thyrotropin-Releasing Hormone).

It had two arms (groups): Thyrotropin releasing hormone (TRH) (experimental) and Saline (placebo comparator).

TRH.

Placebo.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 11 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Provide written informed consent prior to initiation of any study-related procedures. Able to understand and comply with the requirements of the study.

The full record lists 4 inclusion and 23 exclusion criteria; among the exclusions: hospitalized patients; patients with any of the following cardiovascular symptomatology; office systolic bp \> 160mmhg and/or diastolic bp \> 90mmhg.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

Random assignment meant chance, not the researchers, decided who got TRH (Thyrotropin-Releasing Hormone) and who got the comparison, which limits bias.

Each person switched between TRH (Thyrotropin-Releasing Hormone) and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received TRH (Thyrotropin-Releasing Hormone).

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2006-12 with completion listed for 2010-02.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main 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).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of TRH (Thyrotropin-Releasing Hormone) in 11 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the TRH (Thyrotropin-Releasing Hormone) compound page, all human trials.

Our Notes on the Compound

TRH (Thyrotropin-Releasing Hormone): A 3-amino-acid hypothalamic hormone (protirelin) that triggers TSH and prolactin release.

TRH (Thyrotropin-Releasing Hormone) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.