Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer - Full Text View

Sponsors and Collaborators:	University Hospital, Limoges Ipsen
Information provided by:	University Hospital, Limoges
ClinicalTrials.gov Identifier:	NCT00630695

Purpose

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
Lymphocele	Drug: Lanreotide LP 90 Drug: Placebo lanreotide	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Lanreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the Efficacity of Lanreotide LP 90 mg to Minimized the Lymphorrhea Post Axillary Lymphadenectomy in Breast Cancer

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 ]

Estimated Enrollment:	140
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lanreotide LP 90	Drug: Lanreotide LP 90 Lanreotide LP 90
2: Placebo Comparator	Drug: Placebo lanreotide Placebo

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630695

Contacts

Contact: Yves Aubard, MD

5 55 05 61 07 ext 33

yves.aubard@unilim.fr

Locations

France
Hôpital Mère Enfant- CHU de Limoges	Recruiting
Limoges, France, 87042
Principal Investigator: Yves Aubard, MD,PhD

Sponsors and Collaborators

University Hospital, Limoges

Ipsen

Investigators

Study Chair:

Yves Aubard, MD, PhD

CHU de Limoges

More Information

Responsible Party:	CHU de Limoges ( CHU de Limoges )
Study ID Numbers:	2007-003576-19
Study First Received:	February 27, 2008
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00630695
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Limoges:

Axillary lymphocele breast cancer

Study placed in the following topic categories:

Lymphatic Diseases
Lymphocele
Lanreotide
Skin Diseases

Angiopeptin
Breast Neoplasms
Cysts
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents

Therapeutic Uses
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009