NCT04168242已完成不适用
The Psychological Impact of Scalp Cooling in Patients Receiving Chemotherapy for Primary Gynecologic Cancers: a Randomised Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence and grading of chemotherapy induced alopecia
研究概览
简要总结
In gynecologic cancers, many common chemotherapy agents can lead to chemotherapy-induced alopecia. Currently scalp cooling is the most well studied preventive measure. However, its acceptability and its impact on patients' QOL in Asian population is unclear.
详细描述
Dynamic scalp cooling system prevents alopecia by inducing vasoconstriction leading to a reduction of scalp blood flow, thus reducing the delivery of cytotoxic drugs to the hair follicles and reducing follicular metabolic activities. One recent meta-analysis included 10 studies showed that the efficacy was 43% in general.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patients must be at least 18 years old.
- •Patients with primary gynecologic cancers.
- •Patients who are going to receive at least four cycles of chemotherapy that are known to induce alopecia, such as carboplatin, paclitaxel, taxotere, topotecan, etoposide, vincristine and ifosfamide.
- •Patients who are fit to give informed consent.
排除标准
- •Patients who have pre-existing alopecia of CTCAE v5.0 grade 1 or above will be excluded.
- •Patients who have the following conditions will be excluded:
- •scalp or brain metastasis
- •hypothyroidism
- •uncontrolled diabetes
- •liver and / or renal derangement (where liver enzymes and / or creatinine are 1.5x more than upper normal limit)
- •severe untreated anaemia
- •cold sensitivity
- •cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
- •Patients who had brain irradiation.
- •Patients who have documented psychiatric disorders will be excluded.
- •Patients who are pregnant.
结局指标
主要结局
Incidence and grading of chemotherapy induced alopecia
时间窗: 9 months
Will be assessed by Dean's scale Grade 0 - 4 (from 0% to \>75% hair loss)
次要结局
- Anxiety / depression level(9 months)
- Incidence and grading of treatment-related adverse events(9 months)
- Quality-of-life scale(9 months)
研究者
研究点 (1)
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