Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer

University of Limoges (UL)

Status and phase: Completed; Phase 3

Conditions: Lymphocele

Treatments: Drug: Lanreotide LP 90; Drug: Placebo lanreotide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00630695

2007-003576-19

Details and patient eligibility

About

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

Full description

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.

Enrollment: 148 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Lanreotide LP 90

Treatment:

Drug: Lanreotide LP 90

2

Placebo Comparator group

Treatment:

Drug: Placebo lanreotide