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


Phase 3
18 Years
80 Years
Not Enrolling
Female
Lymphocele

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Quantity of lymph collected by the drain

Outcome Time Frame:

D4 post operativly

Safety Issue:

Yes

Principal Investigator

Yves Aubard, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital, Limoges

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2007-003576-19

NCT ID:

NCT00630695

Start Date:

March 2008

Completion Date:

December 2011

Related Keywords:

  • Lymphocele
  • Axillary lymphocele breast cancer
  • Breast Neoplasms
  • Lymphocele

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