Comparative Study of Scalp Cooling System and Chemical Cold Cap on Prevention of Chemotherapy-induced Alopecia in Women With Breast Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- The effects on the prevention of alopecia of two methods
研究概览
简要总结
This is a phase III, single-center, prospective, open-label, randomized,controlled study
详细描述
To conduct a prospective randomized controlled study comparing the effect of scalp cooling system (DigniCap) and chemical cold cap on preventing chemotherapy-induced alopecia in a group of breast cancer patients receiving standard anthracycline followed paclitaxel regimens. To obtain the exact data on the role of different methods of preventing alopecia in Chinese women with breast cancer.
PASS 11 software was used to calculate the sample size. According to the results of previous studies, the hair retention rate of the cold cap group was 67.7%, the hair retention rate of the scalp cooling system group was 50.5%, α=0.05，Power=0.8. The sample size was calculated to be at least 128 cases in each group, 256 cases in total.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients, 18≦age ≦66 years
- •Invasive breast cancer diagnosed with core needle needle biopsy
- •Staging I-II
- •Without chemotherapy contraindications, and planned to receive neoadjuvant chemotherapy with a standard regimen (containing 4-cycle dose-dense anthracycline followed 4-cycle paclitaxel)
- •Attend the study voluntarily, sign the informed consent
排除标准
- •History of malignant tumors
- •With chemotherapy contraindications
- •With severe dermatosis and severe sparsity
- •History of chronic diseases such as cerebrovascular disease, migraine and hyperthyroidism
- •Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection
- •Refuse to join the study
结局指标
主要结局
The effects on the prevention of alopecia of two methods
时间窗: One year after neoadjuvant chemotherapy
To compare the effects of scalp cooling system and chemical cold cap on the prevention of chemotherapy-induced alopecia in breast cancer patients undergoing neoadjuvant chemotherapy containing anthracycline followed paclitaxel. To assess hair status, a total of three photographs of patients'hair in the both groups were taken by study personnel before the start of first chemotherapy cycle, within 2 days before the start of paclitaxel chemotherapy and within 1 week after the last chemotherapy cycle. Photographs captured hair from the top of head. Patients assessed and estimated the percentage of hair loss using WHO classification of acute and subacute toxicity of anticancer drugs. Success was defined as WHO criteria alopecia grade I (\<25% hair loss) or grade II (25%-50% hair loss). Failure was defined as WHO criteria alopecia grade III (\>50% hair loss) or grade IV. The primary efficacy end point was assessed by clinicians who were independent.
次要结局
- Qualify of life(One year after neoadjuvant chemotherapy)
- Psychological stress(One year after neoadjuvant chemotherapy)
研究者
Tao OUYANG
Director of Breast Center of Peking University Cancer Hospital
Peking University