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

Breast Cancer Clinical Trial

— SANDOSTATINE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03791736
• Other study ID #: 2015-03
• Status: Terminated
• Phase: N/A
• Start date: July 6, 2016
• Est. completion date: July 6, 2018

Study information

• Verified date: July 2022
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 6, 2018
• Est. primary completion date: July 6, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphocele

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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®.	The frequency of occurrence of a lymphocele requiring at least one evacuation puncture.	6 months
Secondary	Evaluation of the volume of the punctures	Determined by the volume of the punctures carried out	6 months
Secondary	Evaluation of the cost of this treatment	Determined by the data recovered from the Health Insurance	6 months