NCT01831024Unknown不适用
Clinical Performance, Efficacy and Safety of the DigniCap™ System, a Scalp Hypothermia System, in Preventing Chemotherapy Induced Alopecia in Patients With Early Stage Breast Cancer
Target Health Inc.4 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2013年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Hair loss
研究概览
简要总结
The efficacy and safety of the Dignicap System to prevent chemotherapy induced alopecia will be evaluated in women with early breast cancer undergoing adjuvant or neoadjuvant chemotherapy regimens. The scalp cold cap will be applied at each chemotherapy cycle. Hair loss will be evaluated by patient self assessment of 5 standardized photographs taken prior to each chemotherapy cycle. A concurrent control group not using a cold cap will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Female patients >/= 18 years of age
- •Documented diagnosis of stage I or II breast cancer
- •A planned course of chemotherapy in the adjuvant or neoadjuvant setting with curative intent including one of the following regimens:
- •Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 x 4 - 6 cycles IV every 2 - 3 weeks
- •Docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 x 4 - 6 cycles IV every 3 weeks
- •Paclitaxel 80 mg/m2 weekly IV x at least 12 weeks with or without IV trastuzumab
- •Paclitaxel 175 mg/m2 IV every 2 weeks x 4 - 6 cycles (without an anthracycline)
- •Paclitaxel weekly and carboplatin AUC 2 weekly or AUC 6 every 3 weeks IV x 4 - 6 cycles and trastuzumab IV weekly or every 3 weeks
- •Docetaxel 75 mg/m2 and carboplatin AUC 6 IV every 3 weeks x 4 - 6 cycles and trastuzumab IV weekly or every 3 weeks
- •Targeted agents such as trastuzumab or lapatinib are allowed
- •Plan to complete chemotherapy within 6 months
- •At least two years out from the last chemotherapy causing hair loss with complete recovery of hair
- •Karnofsky performance status >/= 80%
- •Willing and able to sign informed consent for protocol treatment
- •Willing to participate in study procedures including having photographs of the head before the first cycle of chemotherapy and 1 month after the last chemotherapy
- •Willing to enroll in an extension protocol for follow up for 5 years following the end of chemotherapy treatment
排除标准
- •Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
- •Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss
- •A history of whole brain radiation
- •Plans to use a chemotherapy regimen other than those specified in the inclusion criteria. Specifically, patients receiving a regimen including both an anthracycline and a taxane are not eligible for this trial (AC/T, EC/T, TAC, etc.)
- •Concurrent hormone therapy with chemotherapy. Hormone therapy should be used as indicated following completion of chemotherapy
- •Underlying clinically significant liver disease including active viral hepatitis with abnormal liver function tests >1.5 times the upper limit of normal, including alkaline phosphatase, AST, and total bilirubin. Patients with Gilbert´s disease (elevated indirect bilirubin only) will be eligible for participation.
- •Clinically significant renal dysfunction defined as serum creatinine > upper limit of normal.
- •A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up
- •A history of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens
- •Participation in any other clinical investigation or exposure to other investigational agents, drugs, device or procedure that may cause hair loss
- •Intercurrent life-threatening malignancy
- •A history of cold agglutinin disease or cryoglobulinemia.
- •Evidence of untreated or poorly controlled hyper or hypothyroidism
- •A history of silicon allergy
- •American Society of Anesthesiologist Class ≥3
研究组 & 干预措施
Treatment Group
Experimental
Dignicap System
干预措施: Dignicap System (Device)
Control Group
No Intervention
Concurrent age and chemotherapy matched control
结局指标
主要结局
Hair loss
时间窗: 4 weeks after last chemotherapy cycle
5 standardized photographs will be evaluated by the patient using the Dean Scale for alopecia
次要结局
- Hair regrowth(4 Weeks after last chemotherapy)
- Adverse events(6 months)
- Quality of Life(4 Weeks after last chemotherapy cycle)
- Tolerability(Every 2 to 4 weeks for up to 12 weeeks)
研究者
研究点 (4)
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