Clinical Trial: Extended-release of Octreotide (LF-PB) for the Treatment of Seroma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 No
Brief 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 Summary: 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).
Sponsor: Chemi S.p.A.
Current Primary Outcome: Incidence of seromas requiring an aspiration [ Time Frame: Day 28 post surgery ]
Subjects will undergo an echography at the operated axilla at every scheduled visit till Day 28 or until seroma resolution, whichever occurs first. In case of seroma presence the investigator will decide if an aspiration is required; the decision will be based on the clinical investigator's evaluation.
In case of aspiration, the subject with seroma will be considered amenable for the statistical analysis of seroma incidence.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Chemi S.p.A.
Dates:
Date Received: January 27, 2016
Date Started: October 22, 2015
Date Completion:
Last Updated: February 1, 2017
Last Verified: February 2017
