NCT00630695已完成3 期
Evaluation of the Efficacity of Lanreotide LP 90 mg to Minimized the Lymphorrhea Post Axillary Lymphadenectomy in Breast Cancer
University Hospital, Limoges1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Quantity of lymph collected by the drain
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patient (> 18 years),
- •Patient undergoing an axillary lymphadenectomy for breast cancer
- •Patient giving her agreement after being informed
排除标准
- •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
研究组 & 干预措施
1
Experimental
Lanreotide LP 90
干预措施: Lanreotide LP 90 (Drug)
2
Placebo Comparator
干预措施: Placebo lanreotide (Drug)
结局指标
主要结局
Quantity of lymph collected by the drain
时间窗: D4 post operativly
次要结局
- Prevention of lymphocele(D15, D30 and M6)
研究者
研究点 (1)
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