NCT04630080进行中（未招募）不适用
Scalp Cooling Study for the Prevention of Chemotherapy-induced Alopecia in Chinese Breast Cancer Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The success rate of scalp cooling in preventing chemotherapy-induced alopecia
研究概览
简要总结
The Orbis Paxman Hair Loss Prevention System is a new equipment introduced to Hong Kong in 2017. Although this device has been widely used in the United States, Europe and Australia, acceptability, efficacy and safety data in Chinese have not yet been available. The objective of this prospective study is to collect clinical data in Chinese patients using the Orbis Paxman Hair Loss Prevention System to prevent chemotherapy-induced alopecia.
This project seeks to demonstrate that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •i) New diagnosis of breast cancer stage I-III
- •ii) Chinese ethnicity
- •iii) ECOG 0-1
- •iii) Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent
- •iv) Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline and/or taxane based chemotherapy regimen,
- •Defined as one of the following regimens:
- •Adriamycin 60 mg/m2 with cyclophosphamide 600 mg/m2 for 4 cycles (AC) > 5-Fluorouracil 500 mg/m2, Epirubicin 100mg/m2, and cyclophosphamide 500 mg/m2 for 3 cycles, followed by Docetaxel 100 mg/m2 for 3 cycles (FEC-D)
- •AC x 4 cycles, followed by Docetaxel 100 mg/m2 for 4 cycles (AC-D)
- •AC x 4 cycles, followed by Paclitaxel 175 mg/m2 for 4 cycles (AC-P)
- •Docetaxel 75 mg/m2 with cyclophosphamide 600 mg/m2 for 4-6 cycles (DC)
- •Docetaxel 75 mg/m2 with carboplatin AUC of 5-6 for 4-6 cycles (DCb)
- •Concurrent trastuzumab and/or pertuzumab at standard doses is allowed.
- •Administration of chemotherapy on a dose dense schedule with GCSF is allowed.
- •v) Adequate organ functions vi) Normal thyroid stimulating hormone vii) Subjects with history of diabetes must have acceptable HBA1c on study entry viii) Subjects who provide consent and are mentally competent and able to fill in study questionnaires
排除标准
- •i) Subjects with any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)
- •ii) Subjects with cold agglutinin disease or cold urticaria
- •iii) Age ≥ 70 years
- •iv) Personal history of migraines, cluster or tension headaches as defined as actual medical diagnosis by a physician and/ or prescribed medications. If personal history of migraines was related to a past medical problem that is now resolved, subject may go on study at the discretion of the Principal Investigator.
- •v) Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal
- •vi) Serum Albumin < 3.0
- •vii) Subjects with anemia (defined as a hemoglobin < 10)
- •viii) Subjects who have lichen planus or lupus, or other dermatological conditions involving scalp
- •ix) Subjects who are underweight (defined as a BMI < 18.5)
- •x) Subjects who have had previous chemotherapy exposure
研究组 & 干预措施
Scalp Cooling
Experimental
干预措施: Scalp cooling (Device)
结局指标
主要结局
The success rate of scalp cooling in preventing chemotherapy-induced alopecia
时间窗: 2 year
次要结局
- The rate of preceived hair preservation during and after completion of chemotherapy(2 years)
- The disease site specific quality of life during and after completion of chemotherapy(2 years)
- The quality of life during and after completion of chemotherapy(2 years)
- The incidence of treatment-emergent adverse events of scalp cooling(2 years)
研究者
Winnie Yeo
Professor, Department of Clinical Oncology
Chinese University of Hong Kong
研究点 (1)
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