NCT01986140Unknown不适用
Scalp Cooling for Alopecia Prevention (SCALP)
Julie Nangia13 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2014年5月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 236
- 试验地点
- 13
- 主要终点
- Hair Preservation
研究概览
简要总结
Determine 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.
详细描述
Cooling the scalp during chemotherapy may help reduce the chances of losing hair during treatment. The investigators are hoping that using the PAXMAN Orbis Scalp Cooling Device may stop patients who are undergoing chemotherapy from losing their hair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
One blinded observer assesses the patient outcome
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
- •New diagnosis of breast cancer stage 1-2
- •Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent
- •Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline or taxane based chemotherapy regimen,
- •Defined as one of the following regimens: - Adriamycin 60mg/m2 with cyclophosphamide 600mg/m2 - Epirubicin 90-100mg/m2 with cyclophosphamide 600mg/m2 - Doxorubicin 50mg/m2 with 5-Fluroruacil 500mg/m2 and Cyclophosphamide 500mg/m2 - Paclitaxel 80mg-90/m2 weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as a single agent - Docetaxel 100mg/m2 as a single agent - Docetaxel 75mg/m2-100mg/m2 with pertuzumab and traztuzumab at standard doses - Docetaxel 75mg/m2 with cyclophosphamide 600mg/m2 - Docetaxel 75mg/m2 with carboplatin AUC of 6 and trastuzumab at standard doses
- •Concurrent traztuzumab at standard doses is allowed
- •Concurrent pertuzumab at standard doses is allowed
- •Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated.
- •Subjects must have TSH collected within 1 year prior to treatment and found within normal range.
- •If patient has a history of diabetes, Hemoglobin A1c must be drawn within 3 months prior to treatment and found to be within normal limits.
- •CBC and CMP should be done within 4 weeks prior to treatment and found to be within acceptable limits.
排除标准
- •Stage 3 or 4 breast cancer or any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)
- •Baseline alopecia (defined CTCAE v4.0 grade > 0, see appendix B for CTCAE v4.0 scale)
- •Subjects with cold agglutinin disease or cold urticaria
- •Subjects who are scheduled for bone marrow ablation chemotherapy
- •Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or TAC)
- •Male gender
- •Age >= 70 years
结局指标
主要结局
Hair Preservation
时间窗: 4 to 8 Months
The primary efficacy endpoint will be success in hair preservation, defined as CTCAE v 4 alopecia grade \<2, and will be assessed by a healthcare professional who is blinded to study treatment.
次要结局
- Time to First Recurrence and Overall Survival(5 years)
研究者
Julie Nangia
Assistant Professor
Baylor Breast Care Center
研究点 (13)
Loading locations...
相似试验
已完成
2 期
Effectiveness and safety of the hair loss restraint by scalp cooling enforcement addition in the breast cancer chemotherapyD001943Breast cancerJPRN-jRCTs032180224Karata Tomoko1
已完成
2 期
Effect of a scalp cooling device in the prevention of chemotherapy-induced alopecia in breast cancer patientsBreast cancerJPRN-jRCTs042180065Kotani Haruru16
招募中
不适用
Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid TumorsAlopeciaNCT04764357St. Jude Children's Research Hospital40
进行中（未招募）
不适用
Alopecia Prevention Scalp Cooling in Chinese Breast Cancer PatientsBreast CancerNCT04630080Chinese University of Hong Kong25
进行中（未招募）
不适用
Safety of Lower Scalp Cooling Temperature to Prevent Hair Loss From Chemotherapy in Breast Cancer PatientsBreast Cancer Stage IBreast Cancer Stage IIBreast Cancer Stage IIIBreast CancerNCT04180579Memorial Sloan Kettering Cancer Center34