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

Primary Purpose

Breast Cancer, Lymphocele

Status

Terminated

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Injection of sandostatine

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer, axillary clearance, lymphocele

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sandostatine

Arm Description

Injection of Sandostatine

Outcomes

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®.

The frequency of occurrence of a lymphocele requiring at least one evacuation puncture.

Secondary Outcome Measures

Evaluation of the volume of the punctures

Determined by the volume of the punctures carried out

Evaluation of the cost of this treatment

Determined by the data recovered from the Health Insurance

Full Information

NCT ID

NCT03791736

First Posted

December 31, 2018

Last Updated

July 26, 2022

Sponsor

Institut Cancerologie de l'Ouest

1. Study Identification

Unique Protocol Identification Number

NCT03791736

Brief Title

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

Acronym

SANDOSTATINE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Terminated

Why Stopped

The surgical technique is no longer used

Study Start Date

July 6, 2016 (Actual)

Primary Completion Date

July 6, 2018 (Actual)

Study Completion Date

July 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Cancerologie de l'Ouest

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Lymphocele

Keywords

breast cancer, axillary clearance, lymphocele

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sandostatine

Arm Type

Experimental

Arm Description

Injection of Sandostatine

Intervention Type

Procedure

Intervention Name(s)

Injection of sandostatine

Other Intervention Name(s)

Octreotide

Intervention Description

Intramuscular injection of sandostatin 30 mg 3 days before surgery

Primary Outcome Measure Information:

Title

Description

The frequency of occurrence of a lymphocele requiring at least one evacuation puncture.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Evaluation of the volume of the punctures

Description

Determined by the volume of the punctures carried out

Time Frame

6 months

Title

Evaluation of the cost of this treatment

Description

Determined by the data recovered from the Health Insurance

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

EMMANUELLE MARTIN, MD

Organizational Affiliation

INSTITUT DE CANCEROLOGIE DE L'OUEST

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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