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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
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lymphocele focused on measuring Axillary lymphocele breast cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
February 27, 2008
Last Updated
January 13, 2012
Sponsor
University Hospital, Limoges
Collaborators
Ipsen
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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

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Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer

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