CTRI/2017/02/007896进行中(未招募)2 期
Scalp Cooling for the prevention of chemotherapy induced alopecia in breast cancer from a tertiary care cancer center in Indiaâ??.
Access Devices0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •New diagnosis of non-metastatic breast cancer
- •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:
- •ï??EC (Epirubicin 90mg/m2) & (Cyclophosphamide 600 mg/m2) or FEC (5Florouracil 500 mg/m2, Epirubicin 90mg/m2 & Cyclophosphamide 500 mg/m2 x 4 cycles
- •ï??Followed by weekly Paclitaxel (80mg/m2) x 12 weeks or 3 weekly Paclitaxel (175 mg/m2) or Docetaxel (100 mg/m2) x 4 cycles
- •Concurrent trastuzumab at standard doses is allowed.
- •Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated.
排除标准
- •Metastatic breast cancer
- •Baseline alopecia (defined CTCAE v4.0 grade > 0, see Appendix B)
- •Subjects with cold agglutinin disease or cold urticaria.
- •Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or TAC)
- •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.
- •Subjects who have lichen, planus or lupus.
- •Subjects who have had previous chemotherapy exposure.
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