Extended-release of Octreotide (LF-PB) for the Treatment of Seroma

What Was Tested

This registered phase 2 trial tested Octreotide.

This is a multicentre, double blind, randomized placebo controlled trial to assess the effect of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph Node Dissection (ALND).

It had two arms (groups): one (experimental) and Placebo (placebo comparator).

Extended release of octreotide.

Extended release of placebo.

The registry classes the interventions as drug.

More on the Plan

The study will randomize between 24 and 72 subjects that received an ALND.

A staged adaptive design is employed with two intermediate analyses and a final analysis.

The first interim analysis at 24 treated subjects (at least 12 in each group) and the second at 48 treated subjects (at least 24 in each group).

Who Took Part

48 actual participants took part.

It was open to women only 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: Signed informed consent form;. Undergoing breast cancer surgery with axillary lymph node dissection during the current clinical trial;. Negative serum pregnancy test for women of childbearing potential;. Aspartate aminotransferase and alanine aminotransferase \< 2 x the upper limit of normal;. ECOG PS ≤ 1.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: previous axillary surgery on the same armpit (sentinel lymph node surgery is not exclusionary);; previous radiotherapy within five years from study drug administration on the same armpit undergoing surgery in this study;; concomitant participation to other clinical trial;.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

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

It started in 2015-10-22 with completion listed for 2016-07-19.

It ran at 7 sites in Italy (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Incidence of seromas requiring an aspiration (time frame: Day 28 post surgery).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 48 people.

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.