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

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.

Study Overview

• Status: Completed
• Conditions: Seroma
• Intervention / Treatment: Drug: extended release of octreotide; Drug: extended release of 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).

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
      • Az. Osp. Univ. Mater Domini
  • Campania
    • Naples, Campania, Italy, 80131
      • IRCCS Fondazione Pascale
  • Emilia Romagna
    • Ferrara, Emilia Romagna, Italy, 44124
      • Az. Osp. Univ. di Ferrara - Ospedale di Cona
    • Modena, Emilia Romagna, Italy, 41124
      • Az.Osp. Univ. Policlinico di Modena
    • Parma, Emilia Romagna, Italy, 43126
      • Az. Osp. Univ. di Parma
  • Liguria
    • Genova, Liguria, Italy, 16132
      • Irccs Azienda Ospedaliera Universitaria San Martino
  • Piemonte
    • Turin, Piemonte, Italy, 10126
      • Az. Osp. Univ. Città Della Salute e Della Scienza di Torino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LF-PB 30 mg; extended release of octreotide	Drug: extended release of octreotide; 1 intramuscular injection of extended release of octreotide 30 mg; Other Names: LF-PB 30 mg
Placebo Comparator: Placebo; extended release of placebo	Drug: extended release of placebo; 1 intramuscular injection of extended release of placebo; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chemi S.p.A.
• Investigators: Principal Investigator: Paolo Carcoforo, Prof., U.O. Clinica Chirurgica, A. O. Univ. Arcispedale S.Anna - Ferrara

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2015
• Primary Completion (Actual): July 19, 2016
• Study Completion (Actual): July 19, 2016

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Estimate): February 2, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Seroma; Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: LF-PB/14/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED