Back to resultsExtended-release of Octreotide (LF-PB) for the Treatment of Seroma
Primary Purpose
Seroma
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
extended release of octreotide
extended release of placebo
Sponsored by
About this trial
This is an interventional treatment trial for Seroma
Eligibility Criteria
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.
Sites / Locations
- Az. Osp. Univ. Mater Domini
- IRCCS Fondazione Pascale
- Az. Osp. Univ. di Ferrara - Ospedale di Cona
- Az.Osp. Univ. Policlinico di Modena
- Az. Osp. Univ. di Parma
- IRCCS Azienda Ospedaliera Universitaria San Martino
- Az. Osp. Univ. Città Della Salute e Della Scienza di Torino
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LF-PB 30 mg
Placebo
Arm Description
extended release of octreotide
extended release of placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02668588
Brief Title
Extended-release of Octreotide (LF-PB) for the Treatment of Seroma
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 22, 2015 (Actual)
Primary Completion Date
July 19, 2016 (Actual)
Study Completion Date
July 19, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chemi S.p.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seroma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LF-PB 30 mg
Arm Type
Experimental
Arm Description
extended release of octreotide
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
extended release of placebo
Intervention Type
Drug
Intervention Name(s)
extended release of octreotide
Other Intervention Name(s)
LF-PB 30 mg
Intervention Description
1 intramuscular injection of extended release of octreotide 30 mg
Intervention Type
Drug
Intervention Name(s)
extended release of placebo
Other Intervention Name(s)
Placebo
Intervention Description
1 intramuscular injection of extended release of placebo
Primary Outcome Measure Information:
Title
Incidence of seromas requiring an aspiration
Description
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.
Time Frame
Day 28 post surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Carcoforo, Prof.
Organizational Affiliation
U.O. Clinica Chirurgica, A. O. Univ. Arcispedale S.Anna - Ferrara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Az. Osp. Univ. Mater Domini
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
IRCCS Fondazione Pascale
City
Naples
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Az. Osp. Univ. di Ferrara - Ospedale di Cona
City
Ferrara
State/Province
Emilia Romagna
ZIP/Postal Code
44124
Country
Italy
Facility Name
Az.Osp. Univ. Policlinico di Modena
City
Modena
State/Province
Emilia Romagna
ZIP/Postal Code
41124
Country
Italy
Facility Name
Az. Osp. Univ. di Parma
City
Parma
State/Province
Emilia Romagna
ZIP/Postal Code
43126
Country
Italy
Facility Name
IRCCS Azienda Ospedaliera Universitaria San Martino
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Az. Osp. Univ. Città Della Salute e Della Scienza di Torino
City
Turin
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Extended-release of Octreotide (LF-PB) for the Treatment of Seroma
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