NCT01701466终止2 期
A Phase II Study Designed to Evaluate the Value of Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis for Patients Undergoing External Radiation Therapy
Sir Mortimer B. Davis - Jewish General Hospital2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2011年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Maximum skin toxicity
研究概览
简要总结
The purpose of this study is to determine whether NeoVIDERM is effective at preventing radiation dermatitis in patients receiving external beam radiation therapy to the head and neck or breast areas.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For patients receiving radiation to the breast
- •Patients receiving a dose of at least 50 Gy in 25 fractions with concomitant chemotherapy or treated with the McGill technique.
- •Patients able to understand and sign an informed consent form.
- •Patients that do not have active connective tissue disorders.
- •Patients 18 years or older.
- •Patients that did not receive any previous radiation.
- •Patients that do not have any known allergy to any ingredients of the NeoVIDERM cream
- •Patients need to be able to apply the creams themselves or have help with applying the creams.
- •Inclusion criteria: For patients receiving radiation to the head and neck
- •Patients receiving radiotherapy on fields that include both sides of the neck
- •Patients able to understand and sign an informed consent form.
- •Patients that do not have active connective tissue disorders.
- •Patients 18 years or older.
- •Patients that did not receive any previous radiation.
- •Patients that do not have any known allergy to any ingredients of the NeoVIDERM cream
- •Patients need to be able to apply the creams themselves or have help with applying the creams.
排除标准
- •For patients receiving radiation to the breast or the head and neck
- •Patients that have a type V or type VI skin type according to the Fitzpatrick scale (because these patients will likely have less radiodermatitis and if they do, it will be harder to evaluate it).
- •The Fitzpatrick Scale:
- •Type I (scores 0-7) White; very fair; freckles. Always burns, never tans
- •Type II (scores 8-16) White; fair. Usually burns, tans with difficulty
- •Type III (scores 17-25) Beige; very common. Sometimes mild burn, gradually tans
- •Type IV (scores 25-30) Beige with a brown tint; typical Mediterranean Caucasian skin.
- •Rarely burns, tans with ease
- •Type V (scores over 30) Dark brown. Very rarely burns, tans very easily
- •Type VI Black. Never burns, tans very easily
- •Allergic to any ingredient in Neoviderm cream
结局指标
主要结局
Maximum skin toxicity
时间窗: 7 weeks post beginning of radiation treatments
The objective of this study is to determine the occurrence and degree of acute skin toxicity in patients receiving radical radiation therapy with preventive application of neoVIDERM compared to patients treated with institutional standard skin care.
次要结局
未报告次要终点
研究者
Dr. Te Vuong
Director Radiation-oncology department
Sir Mortimer B. Davis - Jewish General Hospital
研究点 (2)
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