Evaluation of the impact of a Sandostatin injection before axillary node dissection on lymphorrhea in patients operated for breast cancer - Sandostatin and lymphorrhea

Institut de Cancérologie de l'Ouest0 个研究点目标入组 67 人开始时间: 2016年6月7日最近更新: 2018年10月1日

适应症

试验速览

暂无简介。

•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

•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

发起方

Institut de Cancérologie de l'Ouest