NCT02668588

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Chemi S.p.A. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Seroma

Interventions

Type	Name	Description
DRUG	extended release of octreotide	1 intramuscular injection of extended release of octreotide 30 mg
DRUG	extended release of placebo	1 intramuscular injection of extended release of placebo

Timeline

• Start date: 2015-10-22
• Primary completion: 2016-07-19
• Completion: 2016-07-19
• First posted: 2016-01-29
• Last updated: 2017-02-02

Locations

7 sites across 1 country: Italy