JPRN-jRCTs032230065招募中Unknown
Study on the efficacy and satisfaction of scalp cooling system DigniCap Delta for chemotherapy-induced Alopecia in breast cancer patients
Tsugawa Koichiro0 个研究点目标入组 21 人开始时间: 2023年5月2日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 21
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
- 年龄范围
- >= 18age old 至 <= 70age old（—）
- 性别
- Female
入选标准
- •(1) Histologically diagnosed as breast cancer
- •(2) Confirmed to receive neo adjuvant or adjuvant chemotherapy for primary breast cancer
- •(3) 18 to 70 years old
- •(4) PS 0-1
- •(5) No history of use of chemotherapy which may cause hair loss
- •(6) Stage I-III female breast cancer patients
- •(7) Combination of 4 cycles of anthracyclines and 4 cycles of taxanes (excluding single doses of each, limited to the treatment order of anthracycline to taxane). Concurrent use of anti-HER2 drugs to HER2-positive patients are permitted.
- •List of applicable regimens:
- •EC (3 weeks * 4 times) followed by DTX (3 weeks * 4 times)
- •dose-dense EC (2 weeks * 4 times) followed by DTX (3 weeks * 4 times)
- •dose-dense EC (2 weeks * 4 times) followed by dose-dense PTX (2 weeks * 4 times)
- •(8) No history of treatment for alopecia (use of hair restorers, wigs, hair transplantation, etc. within 6 months), including the history of any alopecia caused other than chemotherapy (alopecia areata, etc.)
- •(9) Patients who can understand the content of the clinical research and have the ability to sign the consent by their decision
- •(10) Patients who have signed the informed consent to participate in this study
排除标准
- •(1) Patients with conditions of contraindications for DigniCap Delta
- •1. Cold sensitivity
- •2. Cold agglutinin disease (including past history)
- •3. Cryoglobulinemia (including past history)
- •4. Cryofibrinogenemia (including past history)
- •5. Cold urticaria (including past)
- •6. Central nervous system malignant tumor (primary or metastatic)
- •7. Squamous cell carcinoma of the lung
- •8. Small cell carcinoma of the lung
- •9. Cancers of the head and neck
- •10. Skin cancers including melanoma, squamous cell carcinoma, and Merkel cell carcinoma
- •11. Hematologic malignancies treated with curative intent with chemotherapy
- •12. Solid tumor malignancies with a high likelihood of metastases in transit
- •13. Patients scheduled for myeloablative chemotherapy
- •14. Patients who are scheduled to undergo skull irradiation
- •15. Patients who have previously received skull irradiation
- •(2) Patients who are judged to be unsuitable by the doctor's judgment
研究者
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