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
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