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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-22

Study Completion Date

2016-07-19

Brief Summary

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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.

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Detailed Description

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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

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Seroma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LF-PB 30 mg

extended release of octreotide

Group Type EXPERIMENTAL

extended release of octreotide

Intervention Type DRUG

1 intramuscular injection of extended release of octreotide 30 mg

Placebo

extended release of placebo

Group Type PLACEBO_COMPARATOR

extended release of placebo

Intervention Type DRUG

1 intramuscular injection of extended release of placebo

Interventions

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extended release of octreotide

1 intramuscular injection of extended release of octreotide 30 mg

Intervention Type DRUG

extended release of placebo

1 intramuscular injection of extended release of placebo

Intervention Type DRUG

Other Intervention Names

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LF-PB 30 mg Placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No