NCT00840515Unknown不适用
A Phase 2,Double Blind Randomized Study of PraevoSkin,a Melatonin Containing Emulsion, in the Prevention of Radiation Induced Dermatitis.
Pharm Olam Pharmaceuticals Ltd.0 个研究点目标入组 1 人开始时间: 2009年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1
- 主要终点
- Digital Camera
研究概览
简要总结
A phase 2 double blind randomised study of PraevoSkin,a melatonin containing emulsion, in the prevention of radiation induced dermatitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients at least 18 years with unilateral breast cancer following lumpectomy +/- chemotherapy.
- •Planned to receive 50 Gy whole breast irradiation +/- boost to tumor bed.
- •ECOG PERFORMANCE STATUS 0-
- •Capable of giving written informed consent and following instructions for applying study emulsion or placebo as per control.
- •No co-morbidities known to affect radiotherapy reactions.
- •No co-existing acute or chronic skin disease.
- •No evidence of infection or inflammation of breast to be treated.
- •Not receiving chemotherapy during radiotherapy course.Biological therapy (e.g. Herceptin) or hormone therapy will be allowed during the study.
排除标准
- •Chemotherapy within 4 weeks prior to planned start of radiation or chemotherapy planned during radiation.
- •Prior radiotherapy to any site.
- •Collagen vascular disease.
- •Diabetes mellitus requiring medication.
- •Uncontrolled hypertension.
- •Participation in other clinical study.
- •Any contra-indicating to treatment with Melatonin.
- •History of allergy to peanuts or fragrances.
- •History of severe allergic reactions (e.g. asthma).
结局指标
主要结局
Digital Camera
时间窗: Weekly
次要结局
未报告次要终点
研究者
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