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

Seroma Clinical Trial

Official title:
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

Clinical Trial Summary

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).

Recruited patients will be randomly assigned to receive LF-PB 30 mg or placebo.

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02668588
Study type Interventional
Source Chemi S.p.A.
Contact
Status Completed
Phase Phase 2
Start date October 22, 2015
Completion date July 19, 2016
View Details
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