Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

What Was Tested

In this early phase 1 trial, researchers set out to test Octreotide.

This study aims to investigate whether octreotide, a medication used off-label to treat chylothorax, has a direct effect on human lymphatic drainage.

To study the effects of octreotide, the researchers conducted a pre-clinical experiment using human lymphatic vessels mounted in a myograph chamber and a clinical experiment in which a double-blinded, randomized, cross-over trial was conducted in 16 healthy adults.

The results of the study will be used to determine the role of octreotide in the treatment of chylothorax and other lymphatic disorders.

It had two arms (groups): Healthy participant 1 (other) and Healthy participant 2 (other).

The registry classes the interventions as drug.

More on the Plan

This study aimed to investigate whether octreotide, a medication used off-label to treat chylothorax, has a direct effect on human lymphatic drainage.

Chylothorax is a condition in which there is an accumulation of lymphatic fluid in the chest cavity, and the mechanism through which octreotide helps to resolve this condition is not well understood.

The results of the study will be used to determine the role of octreotide in the treatment of chylothorax and to clarify the mechanism through which it acts.

Who Took Part

16 actual participants took part.

It was open to people of any sex aged from 20 years up to 35 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 0 inclusion and 1 exclusion criteria; among the exclusions: no daily medication (except birth control), or allergies towards contrast agents.

How the Study Was Run

Design: randomized, crossover and triple-blind.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Octreotide and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Octreotide.

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

It started in 2020-07-01 with completion listed for 2021-03-26.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Lymph rate (time frame: During infusion). Lymph Pressure (time frame: During infusion). Capillary filtration rate (time frame: During infusion).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Octreotide in 16 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.