A Multicenter controlled trial of PAX-15 Hair Loss Prevention System with chemotherapy-induced alopecia in breast cancer patients in Japan - HOPE study

Century Medical,Inc.0 个研究点目标入组 58 人开始时间: 2019年4月11日最近更新: 2023年10月17日

试验速览

npublished due to the article in submission

•1. Stage 3 or higher breast cancer 2. Any other concurrent malignancy including hematological malignancies 3. Baseline alopecia (defined CTCAE v4.0 grade >= 1) 4. Subjects with cold agglutinin disease or cold urticaria 5. Subjects who are scheduled for bone marrow ablation chemotherapy 6. Personal history of migraines, cluster or tension headaches 7. Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal 8. Serum Albumin < 3.0 g/dL 9. Subjects with anemia (defined as a hemoglobin < 10 g/dL) 10. Abnormal TSH, AND: If high, abnormal free T4 defined as out of normal limits If low, abnormal free T4 or T3 defined as out of normal limits 11. Subjects who have diabetes with a Hgb A1c > 7% 12. Subjects who have lichen planus or lupus 13. Subjects who are underweight (defined as a BMI < 17.5) 14. Subjects who have had previous chemotherapy exposure 15.Subjects with difficulty of the proper cap fitting 16. Subjects with head injury or burn 17. Participation in any clinical trials at present or up to 30 days before consent acquisition. 18.Subjects with difficulty of complying with treatment regimen determined in the protocol 19.Life expectancy of subjects is expected less than 1 year. 20.Subjects determined to be ineligible by an investigator.

发起方

Century Medical,Inc.