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 Details — Status: Completed

Administrative data

• NCT number: NCT02668588
• Other study ID #: LF-PB/14/05
• Status: Completed
• Phase: Phase 2
• First received: January 27, 2016
• Last updated: February 1, 2017
• Start date: October 22, 2015
• Est. completion date: July 19, 2016

Study information

• Verified date: February 2017
• Source: Chemi S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 19, 2016
• Est. primary completion date: July 19, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

• Uncontrolled diabetes;

• Cholelithiasis;

• Human immunodeficiency virus or hepatitis B or C by screening serology;

• Uncontrolled hypothyroidism: if patient is being administered Eutirox/ Levothyroxine (or analogues) and levels of T3, T4 and TSH are confirmed to be within the normal ranges at screening, the patient can be enrolled in this study;

• Pregnant or lactating;

• Ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation;

• Corrected QT (using the Bazett formula, QTc) interval at screening or baseline > 450 msec (as the mean of 3 consecutive readings 5 minutes apart);

• Presence of any disease or use of concomitant medication known to increase the QT interval;

• Clinically significant or relevant abnormal medical history, vital sign, physical examination or laboratory evaluation finding;

• Corticosteroid treatment on a long-term basis (i.e. treatment for more than 3 consecutive days);

• Current or recurrent disease that could affect the results of the clinical or laboratory assessment required for the study.

Related Conditions & MeSH terms

• Seroma

Intervention

Drug:
• extended release of octreotide
1 intramuscular injection of extended release of octreotide 30 mg
• extended release of placebo
1 intramuscular injection of extended release of placebo

Locations

Country	Name	City	State
Italy	Az. Osp. Univ. Mater Domini	Catanzaro	Calabria
Italy	Az. Osp. Univ. di Ferrara - Ospedale di Cona	Ferrara	Emilia Romagna
Italy	IRCCS Azienda Ospedaliera Universitaria San Martino	Genova	Liguria
Italy	Az.Osp. Univ. Policlinico di Modena	Modena	Emilia Romagna
Italy	IRCCS Fondazione Pascale	Naples	Campania
Italy	Az. Osp. Univ. di Parma	Parma	Emilia Romagna
Italy	Az. Osp. Univ. Città Della Salute e Della Scienza di Torino	Turin	Piemonte

Sponsors (1)

Lead Sponsor	Collaborator
Chemi S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of seromas requiring an aspiration	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.	Day 28 post surgery