Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation

Overview

The lymphocele is the main early postoperative complication of axillary clearance for breast cancer patients with rates up to 85%. The usual treatment consists of external drainage. However, this method increases the duration of hospitalization. As a result, some practitioners have abandoned drainage, allowing for ambulatory surgery. If this solution makes it possible to reduce the duration of the hospitalizations, it involves iterative punctures of the axillary hollow in case of lymphocele These punctures may be responsible for pain, hematoma or infection of the operative site. To date, no method has proved superior in terms of decreasing the incidence of lymphocele postoperatively axillary clearance. Octreotide (Sandostatin®) is a peptide, one of whose effects is to reduce the inflammation responsible for lymphoceles. The aim of the study is to inject Sandostatin® before surgery, with the aim of reducing the incidence of seroma by 50% after axillary clearance

Full Title of Study: “Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation In Patients With Breast Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 6, 2018

Interventions

  • Procedure: Injection of sandostatine
    • Intramuscular injection of sandostatin 30 mg 3 days before surgery

Arms, Groups and Cohorts

  • Experimental: Sandostatine
    • Injection of Sandostatine

Clinical Trial Outcome Measures

Primary Measures

  • A 50% decrease in the incidence of lymphocele (30% to 15% progression) following axillary clearance of patients operated for breast cancer (excluding mastectomy) pretreated with an injection of Sandostatin®.
    • Time Frame: 6 months
    • The frequency of occurrence of a lymphocele requiring at least one evacuation puncture.

Secondary Measures

  • Evaluation of the volume of the punctures
    • Time Frame: 6 months
    • Determined by the volume of the punctures carried out
  • Evaluation of possible complications
    • Time Frame: 6 months
    • Determined by frequency and intensity (NCI-CTCAE v4.0) of adverse events,
  • Evaluation of the quality of life
    • Time Frame: 6 months
    • Determined by the quality of life score obtained with the FACT-B questionnaire
  • Evaluation of the cost of this treatment
    • Time Frame: 6 months
    • Determined by the data recovered from the Health Insurance

Participating in This Clinical Trial

Inclusion Criteria

Breast cancer, histologically proven Axillary clearance Elective axillary approach Age ≥ 18 years OMS < 3 Normal hematological and hepatic blood tests Obtaining the signed written consent of the patient Exclusion Criteria:

Axillary clearance with a mastectomy metastatic disease Disorder precluding understanding of trial information or informed consent Pregnancy, breastfeeding women Patient is willing and able to comply with the protocol for the duration of the study including all scheduled treatment, visits and examinations No severe or uncontrolled diabetes Known hypersensitivity to Octreotide Patient with vitamin B12 deficiency Anticoagulant treatment History of cardiovascular disease Other product being tested in the 4 weeks prior to the start of treatment Patient has valid health insurance

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institut Cancerologie de l’Ouest
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • EMMANUELLE MARTIN, MD, Study Director, INSTITUT DE CANCEROLOGIE DE L’OUEST

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