Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer

Lymphocele Clinical Trial

Official title:

Evaluation of the Efficacity of Lanreotide LP 90 mg to Minimized the Lymphorrhea Post Axillary Lymphadenectomy in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630695
• Other study ID #: 2007-003576-19
• Status: Completed
• Phase: Phase 3
• First received: February 27, 2008
• Last updated: January 13, 2012
• Start date: March 2008
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lymphocele

Intervention

Drug:
• Lanreotide LP 90
Lanreotide LP 90
• Placebo lanreotide
Placebo

Locations

Country	Name	City	State
France	Hôpital Mère Enfant- CHU de Limoges	Limoges

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of lymph collected by the drain		D4 post operativly	Yes
Secondary	Prevention of lymphocele		D15, D30 and M6	Yes