EUCTR2018-002406-32-FR进行中（未招募）1 期
HOMEORAD : Randomized Phase III Trial Evaluating Homeopathic Radium Bromatum® Impact on the Prevention and Treatment of Radiodermites in Breast Cancer Patients - HOMEORAD
Institut de Cancérologie Lucien Neuwirth0 个研究点目标入组 232 人开始时间: 2018年10月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 232
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
- 性别
- Female
入选标准
- •- Major patient;
- •- Indication of curative radiotherapy after conservative breast cancer surgery. Accepted radiotherapy scheme: 50 Gy (main) + 16 Gy on the tumor bed (additional dose);
- •- Patient affiliated or entitled to a social security scheme;
- •- Patient who received informed information about the study and who co-signed, with the investigator, a consent to participate in the study.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •- Pregnant or lactating woman;
- •- Legal incapacity or limited legal capacity. Medical or psychological conditions that do not allow the subject to understand the study and sign the consent (articles L.1121-6, L.1121-7, L.1211-8, L.1211-9);
- •- Patient followed by a liberal homeopath;
- •- Patient with bilateral breast cancer;
- •- Patient with in situ breast cancer;
- •- Patient with known cognitive impairment;
- •- Patient with known allergy and / or intolerance and / or malabsorption to fructose, glucose, galactose;
- •- Patient with a known deficiency in sucrase / isomaltase / lactase.
研究者
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