The population includes all patients who must have an axillary node dissection for non-metastatic breast cancer.
Conditions
Interventions
Trade Name: Sandostatine
Product Name: Sandostatin
Pharmaceutical Form: Powder and suspension for suspension for injection
Sponsors
Institut de Cancérologie de l'Ouest
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Breast cancer, histologically proven 2) Axillary node dissection programmed for breast cancer (+/-lumpectomy) 3) Elective axillary surgery 4) Age greater than or equal to 18 years 5) Performans Status (WHO): 0, 1 or 2 6) Satisfactory hematologic and hepatic results: Polymorphonuclear neutrophils higher or equal to 1.0 x109 / L, platelets greater than or equal to 100 x 109 / L, Total bilirubin less than or equal to 2 x ULN AST (SGOT) and ALT (SGPT) less than or equal to 3 x ULN (if hepatic metastasis less than or equal to 5 x ULN), PAL less than or equal to 5 x ULN 7) Informed Consent, dated and signed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 67 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 67
Exclusion criteria
Exclusion criteria: 1) Axillary node dissection associated with a mastectomy 2) Metastatic Disease 3) Psychiatric illness disrupting understanding of the trial and the informed and voluntary consent 4) Pregnancy, breastfeeding 5) Patient can not submit to monitoring protocol for psychological, social, family or geographical reasons. 6) Known hypersensitivity to octreotide 7) Processing ciclosporin 8) Patient with uncontrolled diabetes 9) Patient with vitamin B12 deficiency 10) Anticoagulant therapy 11) History of cardiovascular disease 12) Other product being tested in the four weeks preceding the start of treatment 13) A person who is not affiliated to a system of social security or receiving such a plan 14) Patient under guardianship or private guardianship of freedom
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to reduce by 50% the incidence of lymphorrhea (change from 30% to 15%) following axillary node dissection in patients operated for breast cancer (without mastectomy) pre-treated with an injection of Sandostatine®.;Secondary Objective: In this study, we have several secondary objectives: - Evaluation of the volume of punctures, - Evaluation of possible complications, - Evaluation of Sandostatine® tolerance, - Evaluation of the quality of life, - Evaluation of the cost of this care (medico-economic evaluation).;Primary end point(s): The primary endpoint is the occurrence frequency of a lymphorrhea requiring at least one punction;Timepoint(s) of evaluation of this end point: 2 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints will be: - The volume of punctures performed, - The frequency and intensity (NCI-CTCAE v4.0) of adverse events, - The quality of life score with the FACT-B questionnaire followed at 1 month and 6 months compared to baseline, - Medico-economic study will be made according to the Health Insurance (the cost of injection punctures (Act) and the associated transport costs (distance and means of transport)).;Timepoint(s) of evaluation of this end point: 6 month | — |
Countries
France
Contacts
Public ContactMagali BALAVOINE
Institut de Cancérologie de l'Ouest
Outcome results
None listed