Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer
Primary Purpose
Lymphocele
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Lanreotide LP 90
Placebo lanreotide
Sponsored by
About this trial
This is an interventional prevention trial for Lymphocele focused on measuring Axillary lymphocele breast cancer
Eligibility 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
Sites / Locations
- Hôpital Mère Enfant- CHU de Limoges
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Lanreotide LP 90
Outcomes
Primary Outcome Measures
Quantity of lymph collected by the drain
Secondary Outcome Measures
Prevention of lymphocele
Full Information
NCT ID
NCT00630695
First Posted
February 27, 2008
Last Updated
January 13, 2012
Sponsor
University Hospital, Limoges
Collaborators
Ipsen
1. Study Identification
Unique Protocol Identification Number
NCT00630695
Brief Title
Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer
Official Title
Evaluation of the Efficacity of Lanreotide LP 90 mg to Minimized the Lymphorrhea Post Axillary Lymphadenectomy in Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Limoges
Collaborators
Ipsen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphocele
Keywords
Axillary lymphocele breast cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Lanreotide LP 90
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lanreotide LP 90
Intervention Description
Lanreotide LP 90
Intervention Type
Drug
Intervention Name(s)
Placebo lanreotide
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Quantity of lymph collected by the drain
Time Frame
D4 post operativly
Secondary Outcome Measure Information:
Title
Prevention of lymphocele
Time Frame
D15, D30 and M6
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Aubard, MD, PhD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Mère Enfant- CHU de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
12. IPD Sharing Statement
Learn more about this trial
Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer
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