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

Sponsor

Institut Cancerologie de l'Ouest (Other)

Overall Status

Terminated

CT.gov ID

NCT03791736

Collaborator

(none)

Enrollment

Arm

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Lymphocele	Procedure: Injection of sandostatine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

A phase II prospective, single-center, non-randomized study.A phase II prospective, single-center, non-randomized study.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation In Patients With Breast Cancer

Actual Study Start Date :

Jul 6, 2016

Actual Primary Completion Date :

Jul 6, 2018

Actual Study Completion Date :

Jul 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sandostatine Injection of Sandostatine	Procedure: Injection of sandostatine Intramuscular injection of sandostatin 30 mg 3 days before surgery Other Names: Octreotide

Arm

Intervention/Treatment

Experimental: Sandostatine

Injection of Sandostatine

Procedure: Injection of sandostatine

Intramuscular injection of sandostatin 30 mg 3 days before surgery

Other Names:

Octreotide

Outcome Measures

Primary Outcome 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®. [6 months]
The frequency of occurrence of a lymphocele requiring at least one evacuation puncture.

Secondary Outcome Measures

Evaluation of the volume of the punctures [6 months]
Determined by the volume of the punctures carried out
Evaluation of the cost of this treatment [6 months]
Determined by the data recovered from the Health Insurance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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