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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02668588
• Date of registration: 27/01/2016
• Prospective Registration: No
• Primary sponsor: Chemi S.p.A.
• Public title: Extended-release of Octreotide (LF-PB) for the Treatment of Seroma
• Scientific 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
• Date of first enrolment: October 22, 2015
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02668588
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Italy

Contacts

• Name: Paolo Carcoforo, Prof.
• Affiliation: U.O. Clinica Chirurgica, A. O. Univ. Arcispedale S.Anna - Ferrara

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Seroma

Intervention(s)

Drug: extended release of placebo

Drug: extended release of octreotide

Primary Outcome(s)

Incidence of seromas requiring an aspiration [Time Frame: Day 28 post surgery]

Secondary ID(s)

LF-PB/14/05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors