Evaluation of the Effects of Pasireotide LAR Administration on Lymphocele Prevention after Axillary Node Dissection for Breast Cancer: Results of a Randomized Non-Comparative Phase 2 Study

What Was Tested

Researchers studied Somatostatin and Pasireotide in this randomized controlled trial publication.

Who Took Part

By PubMed's age tags, the people studied were adults, middle-aged adults and older adults, women only.

All female patients for whom mastectomy and axillary lymph node dissection were indicated were eligible for the study, including patients who had received neo-adjuvant chemotherapy.

Main exclusion criteria were related to diabetes, cardiac insufficiency, disorder of cardiac conduction or hepatic failure.

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

Random assignment meant chance, not the researchers, decided who got Somatostatin and who got the comparison, which limits bias.

As a double-blind Somatostatin study, the assignments were hidden from both participants and investigators until the end.

A placebo (an inactive look-alike) gave the Somatostatin group a baseline to be compared against.

This prospective, double-blind, randomised, placebo-controlled, phase 2 trial was conducted in two secondary care centres.

The study was conducted in a double-blind manner.

What Was Measured

PubMed files the paper under topics including Axilla, Breast Neoplasms, Lymph Node Excision, Lymphatic Metastasis, Lymphocele, Mastectomy and Neoplasm Staging.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Somatostatin and Pasireotide.

Its findings take up roughly 8 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2016 (PloS one), a journal based in United States.

More context: the Somatostatin compound page and the Pasireotide compound page, all human trials.