Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer

University Hospital, Limoges148 enrolled

Overview

Injection the day before surgery of 90 mg of Lanreotide LP sub-cutaneously or placebo. Evaluation of the lymphorrhea in the 2 arms of the study

Patients will be recruited among patient refered to our department for a breast cancer and needing an axillary dissection. Enrolled patients will have an injection of Lanreotide or placebo the day before surgery when they arrive in their room. The quantity of lymph in axillary drain will by daily noted until day 4. The patient will be evaluated at D15, D30 and M6 for pain, lymphocele and adverse events. Data will be compared in the 2 groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

148

Conditions

Lymphocele

Interventions

Lanreotide LP 90DRUG

Lanreotide LP 90

Placebo lanreotideDRUG

Placebo

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patient (\> 18 years), * Patient undergoing an axillary lymphadenectomy for breast cancer * Patient giving her agreement after being informed Exclusion Criteria: * Patients that don't understand the trial * Type 2 diabetic patients * Cyclosporine treatment * Biliary lithiasis * Pregnancy or breast feeding * Allergic reaction to Lanréotide or same class treatments * Patient included in another trial within the last 30 days

Locations (1)

Hôpital Mère Enfant- CHU de Limoges

Limoges, France

Outcomes

Primary Outcomes

Quantity of lymph collected by the drain

Time frame: D4 post operativly

Secondary Outcomes

Prevention of lymphocele

Time frame: D15, D30 and M6

Data from ClinicalTrials.gov

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