Extended-release of Octreotide (LF-PB) for the Treatment of Seroma
This trial is active, not recruiting.
|Treatments||extended release of octreotide, extended release of placebo|
|Start date||October 2015|
|End date||May 2016|
|Trial size||48 participants|
|Trial identifier||NCT02668588, LF-PB/14/05|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Catanzaro, Italy||Az. Osp. Univ. Mater Domini||no longer recruiting|
|Naples, Italy||IRCCS Fondazione Pascale||no longer recruiting|
|Ferrara, Italy||Az. Osp. Univ. di Ferrara - Ospedale di Cona||no longer recruiting|
|Modena, Italy||Az.Osp. Univ. Policlinico di Modena||no longer recruiting|
|Parma, Italy||Az. Osp. Univ. di Parma||no longer recruiting|
|Genova, Italy||IRCCS Azienda Ospedaliera Universitaria San Martino||no longer recruiting|
|Turin, Italy||Az. Osp. Univ. Città Della Salute e Della Scienza di Torino||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Incidence of seromas requiring an aspiration
time frame: Day 28 post surgery
Female participants at least 18 years old.
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.
|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|
|Principal investigator||Paolo Carcoforo, Prof.|
|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).|
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