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

NCT03791736 | Terminated DMC

• 1 other identifier: 2015-03
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

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

Conditions

Breast Cancer; Lymphocele

Keywords

breast cancer; axillary clearance; lymphocele

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of the volume of the punctures

  6 months

• Evaluation of the cost of this treatment

  6 months

Study Arms (1)

Sandostatine

EXPERIMENTAL

Injection of Sandostatine

Procedure: Injection of sandostatine

Interventions

Injection of sandostatine PROCEDURE

Intramuscular injection of sandostatin 30 mg 3 days before surgery

Also known as: Octreotide

Sandostatine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

MeSH Terms

Conditions

Breast Neoplasms; Lymphocele

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Cysts; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• EMMANUELLE MARTIN, MD

  INSTITUT DE CANCEROLOGIE DE L'OUEST

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: January 3, 2019
• Study Start: July 6, 2016
• Primary Completion: July 6, 2018
• Study Completion: July 6, 2018
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share