Prevention of Lymphorrhea by Lanreotide in Axillary Disse... | NCT00630695

Studies
Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer

NCT00630695

Sponsor

University Hospital, Limoges

Status

Completed

Last Update Posted

Jan 16, 2012Estimated

Enrollment

148Actual

Phase

Phase 3

Conditions

Lymphocele

Interventions

Lanreotide LP 90
Placebo lanreotide

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Jun 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Feb 27, 2008

First Submission Date that Met QC Criteria

Feb 27, 2008

First Posted Date

Mar 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2012

Last Update Posted Date

Jan 16, 2012Estimated

Name	Class
Ipsen	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

148Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Lanreotide LP 90	Drug: Lanreotide LP 90
2	Placebo Comparator		Drug: Placebo lanreotide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lanreotide LP 90	Drug	Lanreotide LP 90	1
Placebo lanreotide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quantity of lymph collected by the drain		D4 post operativly

Secondary Outcomes

Measure	Description	Time Frame
Prevention of lymphocele		D15, D30 and M6

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yves Aubard, MD, PhD	University Hospital, Limoges	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Mère Enfant- CHU de Limoges		Limoges		87042	France

Condition Browse Module

MeSH Terms

ID	Term
D008210	Lymphocele

Ancestor Terms

ID	Term
D003560	Cysts
D009369	Neoplasms
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided