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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00630695
Other study ID # 2007-003576-19
Secondary ID
Status Completed
Phase Phase 3
First received February 27, 2008
Last updated January 13, 2012
Start date March 2008
Est. completion date December 2011

Study information

Verified date January 2012
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date December 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Lanreotide LP 90
Lanreotide LP 90
Placebo lanreotide
Placebo

Locations

Country Name City State
France Hôpital Mère Enfant- CHU de Limoges Limoges

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Limoges Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quantity of lymph collected by the drain D4 post operativly Yes
Secondary Prevention of lymphocele D15, D30 and M6 Yes
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