Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00630695
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : January 16, 2012
Information provided by:
University Hospital, Limoges

Brief 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

Condition or disease Intervention/treatment Phase
Lymphocele Drug: Lanreotide LP 90 Drug: Placebo lanreotide Phase 3

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  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of the Efficacity of Lanreotide LP 90 mg to Minimized the Lymphorrhea Post Axillary Lymphadenectomy in Breast Cancer
Study Start Date : March 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Lanreotide LP 90
Drug: Lanreotide LP 90
Lanreotide LP 90
Placebo Comparator: 2 Drug: Placebo lanreotide

Primary Outcome Measures :
  1. Quantity of lymph collected by the drain [ Time Frame: D4 post operativly ]

Secondary Outcome Measures :
  1. Prevention of lymphocele [ Time Frame: D15, D30 and M6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00630695

Hôpital Mère Enfant- CHU de Limoges
Limoges, France, 87042
Sponsors and Collaborators
University Hospital, Limoges
Study Chair: Yves Aubard, MD, PhD University Hospital, Limoges

Responsible Party: CHU de Limoges Identifier: NCT00630695     History of Changes
Other Study ID Numbers: 2007-003576-19
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: January 16, 2012
Last Verified: January 2012

Keywords provided by University Hospital, Limoges:
Axillary lymphocele breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Lymphatic Diseases
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs