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临床试验/CTRI/2017/02/007896
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??.

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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.

研究者

发起方
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