NCT00630695

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2008

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 16, 2012

Status Verified

January 1, 2012

Enrollment Period

3.3 years

First QC Date

February 27, 2008

Last Update Submit

January 13, 2012

Conditions

Lymphocele

Keywords

Axillary lymphocele breast cancer

Outcome Measures

Primary Outcomes (1)

  • Quantity of lymph collected by the drain

    D4 post operativly

Secondary Outcomes (1)

  • Prevention of lymphocele

    D15, D30 and M6

Study Arms (2)

1

EXPERIMENTAL

Lanreotide LP 90

Drug: Lanreotide LP 90

2

PLACEBO COMPARATOR
Drug: Placebo lanreotide

Interventions

Lanreotide LP 90DRUG

Lanreotide LP 90

1
Placebo lanreotideDRUG

Placebo

2

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient (\> 18 years),
  • Patient undergoing an axillary lymphadenectomy for breast cancer
  • Patient giving her agreement after being informed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Mère Enfant- CHU de Limoges

Limoges, 87042, France

Location

MeSH Terms

Conditions

Lymphocele

Condition Hierarchy (Ancestors)

CystsNeoplasmsLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Yves Aubard, MD, PhD

    University Hospital, Limoges

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2008

First Posted

March 7, 2008

Study Start

March 1, 2008

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

January 16, 2012

Record last verified: 2012-01

Locations

FR(1)