NCT02839473已完成3 期
Hydrosorb® Versus Control (Water Based Spray) in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 4
- 主要终点
- local treatment failure defined as interruption of radiotherapy because of skin radiotoxicity or change of local care because skin alteration.
研究概览
简要总结
The primary objective consisted of avoiding deterioration and/or restoring the integrity of the skin of patients treated by radiotherapy, right from the first signs of grade 1 or 2 radiation dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women treated by normo fractionated radiotherapy for breast cancer
- •Presenting grade 1 or 2 radiation dermatitis during the treatment and who provided their written informed consent were included in the study.
- •Exclusion criteria:
- •Were male patients
- •Radiation dermatitis already treated or caused by another treatment
- •Subjects deprived of their freedom or under guardianship
- •Subjects in whom medical follow-up was impossible
- •A cancer wound or skin flap on the irradiated zone
- •A history of allergic skin reaction
- •Concomitant chemotherapy or concomitant bevacizumab therapy and bilateral irradiation.
排除标准
- 未提供
结局指标
主要结局
local treatment failure defined as interruption of radiotherapy because of skin radiotoxicity or change of local care because skin alteration.
时间窗: through study completion, an average of 3 years
次要结局
- quality of life assessed with the Dermatology Life Quality Index questionnaire(day0, day 14, day 28)
- skin colorimetry measured by a colorimeter(day0, day 7, day 14, day 21, day 28)
- pain level assessed by the visual analog pain scale(day0, day 7, day 14, day 21, day 28)
研究者
研究点 (4)
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