DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer

Information source: University Hospital, Limoges
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphocele

Intervention: Lanreotide LP 90 (Drug); Placebo lanreotide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University Hospital, Limoges

Official(s) and/or principal investigator(s):
Yves Aubard, MD, PhD, Study Chair, Affiliation: University Hospital, Limoges

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

Clinical Details

Official title: Evaluation of the Efficacity of Lanreotide LP 90 mg to Minimized the Lymphorrhea Post Axillary Lymphadenectomy in Breast Cancer

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

Primary outcome: Quantity of lymph collected by the drain

Secondary outcome: Prevention of lymphocele

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Female.

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

Locations and Contacts

Hôpital Mère Enfant- CHU de Limoges, Limoges 87042, France
Additional Information

Starting date: March 2008
Last updated: January 13, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017