Clinical trial NCT03791736: Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation
Official title: Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation In Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lymphocele
Keywords: breast cancer
axillary clearance
lymphocele
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A phase II prospective, single-center, non-randomized study.
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: 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®.
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of the volume of the punctures
timeFrame: 6 months
measure: Evaluation of the cost of this treatment
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: INSTITUT DE CANCEROLOGIE DE L'OUEST
name: EMMANUELLE MARTIN, MD
role: STUDY_DIRECTOR
References: