Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer

January 13, 2012 updated by: University Hospital, Limoges

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87042
        • Hôpital Mère Enfant- CHU de Limoges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Placebo lanreotide
Placebo
Experimental: 1
Lanreotide LP 90
Drug: Lanreotide LP 90
Lanreotide LP 90

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantity of lymph collected by the drain
Time Frame: D4 post operativly
D4 post operativly

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevention of lymphocele
Time Frame: D15, D30 and M6
D15, D30 and M6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Collaborators

Ipsen

Investigators

  • Study Chair: Yves Aubard, MD, PhD, University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

February 27, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

January 16, 2012

Last Update Submitted That Met QC Criteria

January 13, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-003576-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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