EUCTR2014-005289-31-IT进行中（未招募）1 期
A multicentre, double blind, randomized placebo controlled trial to assess the effect of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph Node Dissection - Seroma after axillary Lymph Node Dissection
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CHEMI S.P.A.
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Signed informed consent form;
- •2.Female aged = 18 years;
- •3.Undergone breast cancer surgery with axillary lymph node dissection during the current clinical trial;
- •4.Negative serum pregnancy test for women of childbearing potential;
- •5.Aspartate aminotransferase and alanine aminotransferase < 2x the upper limit of normal;
- •6.ECOG PS = 1;
- •7.Compliant with the required protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1.Previous axillary surgery on the same armpit (sentinel lymph node surgery is not exclusionary);
- •2.Previous radiotherapy within five years from study drug administration on the same armpit undergoing surgery in this study;
- •3.Concomitant participation to other clinical trials;
- •4.Uncontrolled diabetes;
- •5.Cholelithiasis;
- •6.Human immunodeficiency virus or hepatitis B or C by screening serology;
- •7.Uncontrolled hypothyroidism: if patient is being administered Eutirox/ Levothyroxine (or analogues) and levels of T3, T4 and TSH are confirmed to be within the normal ranges at screening, the patient can be enrolled in this study;
- •8.Pregnant or lactating;
- •9.Ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation;
- •10.Corrected QT (using the Bazett formula, QTc) interval at screening or baseline > 450 msec (as the mean of 3 consecutive readings 5 minutes apart). Presence of any disease or use of concomitant medication known to increase the QT interval;
- •11.Clinically significant or relevant abnormal medical history, vital sign, physical examination or laboratory evaluation finding;
- •12.Corticosteroid treatment on a long-term basis. Acute use of corticosteroids to prevent hypersensitivity reactions before surgery is not considered an exclusion criterion;
- •13.Current or recurrent disease that could affect the results of the clinical or laboratory assessment required for the study.
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