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Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer

This study has been completed.
Information provided by:
University Hospital, Limoges Identifier:
First received: February 27, 2008
Last updated: January 13, 2012
Last verified: January 2012
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 Intervention Phase
Drug: Lanreotide LP 90
Drug: Placebo lanreotide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by University Hospital, Limoges:

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

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

Enrollment: 148
Study Start Date: March 2008
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Lanreotide LP 90
Drug: Lanreotide LP 90
Lanreotide LP 90
Placebo Comparator: 2 Drug: Placebo lanreotide

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.


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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: CHU de Limoges Identifier: NCT00630695     History of Changes
Other Study ID Numbers: 2007-003576-19
Study First Received: February 27, 2008
Last Updated: January 13, 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 processed this record on April 28, 2017