NCT01008774已完成不适用
A Comparison of Different Scalp Cooling Systems for the Prevention of Chemotherapy Induced Alopecia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Grade III or IV alopecia according to the WHO criteria
研究概览
简要总结
Primary objective:
- Rate of complete chemotherapy induced alopecia (WHO grade III or IV, physician grading)
Secondary objective:
- Compliance to scalp cooling procedure
- Received number of cycles of chemotherapy in each subgroup
- Patient perception of scalp cooling procedure
- Side effects of scalp cooling systems
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Any solid tumor malignancy receiving docetaxel (Taxotere®) 1st line chemotherapy treatment with the exception of regimen containing concomitant anthracycline treatment; sequential anthracycline/docetaxel treatment is permitted.
- •Performance Status ECOG <= 2
- •Absence of alopecia at inclusion
排除标准
- •Chemotherapy regimen including concomitant anthracycline treatment
- •Raynaud's disease or phenomenon
- •Cold agglutinin disease
- •Cryoglobulinemia
- •Cryofibrinogenemia
- •Scalp metastasis
- •Pregnancy or Lactation
- •Preexisting alopecia of any grade; notably androgenetic alopecia
研究组 & 干预措施
A
Experimental
干预措施: Paxman Cooling Machine (Device)
B
Active Comparator
干预措施: Cold Caps (Device)
C
No Intervention
结局指标
主要结局
Grade III or IV alopecia according to the WHO criteria
时间窗: D1 of each cycle and D+21 after last cycle of chemotherapy
次要结局
- Side effects of scalp cooling systems(D1 of each cycle and D+21 after last cycle of chemotherapy)
- Compliance to scalp cooling procedure(D1 of each cycle and D+21 after last cycle of chemotherapy)
研究者
研究点 (1)
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