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Clinical Trial Summary

This is a phase III, single-center, prospective, open-label, randomized,controlled study


Clinical Trial Description

To conduct a prospective randomized controlled study comparing the effect of scalp cooling system (DigniCap) and chemical cold cap on preventing chemotherapy-induced alopecia in a group of breast cancer patients receiving standard anthracycline followed paclitaxel regimens. To obtain the exact data on the role of different methods of preventing alopecia in Chinese women with breast cancer. PASS 11 software was used to calculate the sample size. According to the results of previous studies, the hair retention rate of the cold cap group was 67.7%, the hair retention rate of the scalp cooling system group was 50.5%, α=0.05,Power=0.8. The sample size was calculated to be at least 128 cases in each group, 256 cases in total. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03711877
Study type Interventional
Source Peking University
Contact Xinying Yu, Master
Phone 0086-10-88271119
Email cindy1104@sohu.com
Status Recruiting
Phase Phase 3
Start date March 7, 2019
Completion date December 31, 2023

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